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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02571777
Registration number
NCT02571777
Ethics application status
Date submitted
5/10/2015
Date registered
8/10/2015
Date last updated
22/07/2020
Titles & IDs
Public title
Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
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Scientific title
A Multicenter, Randomized, 52-week, Double-blind, Parallelgroup, Active Controlled Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
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Secondary ID [1]
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2015-002899-25
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Secondary ID [2]
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CQVM149B2302
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Respiratory
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0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - QVM149 150/50/160
Treatment: Drugs - QVM149 150/50/80
Treatment: Drugs - QMF149 150/320
Treatment: Drugs - QMF149 150/160
Treatment: Drugs - salmeterol/fluticasone
Experimental: QVM149 150/50/160 µg o.d. - QVM149 150/50/160 µg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Experimental: QVM149 150/50/80 µg o.d. - QVM149 150/50/80 µg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Active Comparator: QMF149 150/320 µg o.d. - QMF149 150/320 µg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Active Comparator: QMF149 150/160 µg o.d. - QMF149 150/160 µg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Active Comparator: Salmeterol/fluticasone 50/500 µg b.i.d. - Salmeterol xinafoate /fluticasone propionate 50/500 µg twice daily (b.i.d.) delivered via Accuhaler®
Treatment: Drugs: QVM149 150/50/160
Treatment: Drugs: QVM149 150/50/80
Treatment: Drugs: QMF149 150/320
Treatment: Drugs: QMF149 150/160
Treatment: Drugs: salmeterol/fluticasone
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26
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Assessment method [1]
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Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
The primary endpoint considered the following 2 comparison groups:
QVM149 150/50/80 µg o.d. compared with QMF149 150/160 µg o.d. both delivered via Concept1
QVM149 150/50/160 µg o.d. compared with QMF149 150/320 µg o.d. both delivered via Concept1.
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Timepoint [1]
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26 weeks
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Secondary outcome [1]
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Asthma Control Questionnaire (ACQ-7) at Week 26 and Week 52
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Assessment method [1]
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The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The ACQ-7 total score reported below was calculated as the mean of scores of all 7 items and ranged between 0 and 6, with higher scores indicating worse asthma symptom control.
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Timepoint [1]
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26 weeks, 52 weeks
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Secondary outcome [2]
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Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus Salmeterol/Fluticasone at Week 26
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Assessment method [2]
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Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
This secondary endpoint considered the following 2 comparison groups:
QVM149 150/50/80 µg o.d. via Concept1 compared with salmeterol/fluticasone 50/500 µg b.i.d. via Accuhaler®
QVM149 150/50/160 µg o.d. via Concept 1 compared with salmeterol/fluticasone 50/500 µg b.i.d. via Accuhaler®
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Timepoint [2]
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26 weeks
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Secondary outcome [3]
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Trough FEV1 at Week 52
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Assessment method [3]
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Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
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Timepoint [3]
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52 weeks
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Secondary outcome [4]
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Pre-dose Forced Vital Capacity (FVC) at Week 4 and Week 12
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Assessment method [4]
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Pre-dose FVC is defined as average of the two FVC measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FVC is the total amount of air exhaled during the FEV test.
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Timepoint [4]
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4 weeks, 12 weeks
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Secondary outcome [5]
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Trough Forced Expiratory Flow (FEF) Between 25% and 75% of FVC (FEF25-75) at 52 Weeks
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Assessment method [5]
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FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.
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Timepoint [5]
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Up to Week 52
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Secondary outcome [6]
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Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
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Assessment method [6]
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PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose) at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used.
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Timepoint [6]
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Baseline, 26 weeks, 52 weeks
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Secondary outcome [7]
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Change From Baseline in Percentage of Asthma Symptom-free Days Over 52 Weeks
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Assessment method [7]
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All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms.
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Timepoint [7]
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Baseline, 52 weeks
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Secondary outcome [8]
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Change From Baseline in Percentage of Days With no Daytime Symptoms Over 52 Weeks
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Assessment method [8]
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All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems).
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Timepoint [8]
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Baseline, 52 weeks
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Secondary outcome [9]
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Change From Baseline in Percentage of Nights With no Night-time Awakenings Over 52 Weeks
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Assessment method [9]
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All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).
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Timepoint [9]
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Baseline, 52 weeks
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Secondary outcome [10]
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Change From Baseline in Percentage of Mornings With no Symptoms on Rising Over 52 Weeks
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Assessment method [10]
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All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).
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Timepoint [10]
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Baseline, 52 weeks
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Secondary outcome [11]
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Change From Baseline in Percentage of Days Without Rescue Medication Use Over 26 and 52 Weeks
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Assessment method [11]
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Percentage of days without rescue medication usage (100 µg salbutamol/90 µg albuterol via metered-dose inhaler) as recorded by e-diary over 26 and 52 weeks of treatment.
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Timepoint [11]
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Baseline, 26 weeks, 52 weeks
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Secondary outcome [12]
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Percentage of Patients Achieving the Minimal Clinically Important Difference (MCID) ACQ = 0.5 at Week 26 and Week 52
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Assessment method [12]
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Change from baseline in ACQ-7 scores of = 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions.
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Timepoint [12]
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26 weeks, 52 weeks
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Secondary outcome [13]
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Time to First Hospitalization for Asthma Exacerbation
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Assessment method [13]
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Time from start of treatment until the first event (hospitalization for asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the start date of the hospitalization was considered to calculate the time to event (i.e., the number of days from start of treatment up to the event start date).
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Timepoint [13]
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52 weeks on average, up to 416 days
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Secondary outcome [14]
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Time to First Asthma Exacerbation by Exacerbation Category
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Assessment method [14]
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Time from start of treatment until the first event (asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the start date of the exacerbation was considered to calculate the time to event (i.e., the number of days from start of treatment up to the event start date).
The exacerbation categories were: All (mild, moderate and severe), combination of moderate or severe and severe.
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Timepoint [14]
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52 weeks on average, up to 416 days
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Secondary outcome [15]
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Annual Rate of Asthma Exacerbations by Exacerbation Category
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Assessment method [15]
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The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
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Timepoint [15]
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52 weeks
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Secondary outcome [16]
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Duration in Days of Asthma Exacerbations by Exacerbation Category
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Assessment method [16]
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The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
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Timepoint [16]
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Up to Week 52
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Secondary outcome [17]
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Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
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Assessment method [17]
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The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
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Timepoint [17]
0
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Up to Week 52
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Secondary outcome [18]
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Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbation
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Assessment method [18]
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Time from start of treatment until the first event (permanent discontinuation of study medication due to asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the date of the discontinuation of study medication was considered to calculate the time to event.
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Timepoint [18]
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52 weeks on average, up to 416 days
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Secondary outcome [19]
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Total Amount of Oral Corticosteroid Used (in Prednisone-equivalent mg Doses) to Treat Asthma Exacerbations
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Assessment method [19]
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The treatment of asthma exacerbations including the initiation of systemic corticosteroids were done according to investigator's or treating physician's medical judgement and in line with national and international recommendations. If systemic corticosteroids were required, a participant could return to the study after successfully completing a taper of approximately 7-10 days.
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Timepoint [19]
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Up to Week 52
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Secondary outcome [20]
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Change From Baseline in Percentage of Rescue Medication Free Days Over 26 and 52 Weeks
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Assessment method [20]
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All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. Rescue medication free days is defined as any day where the participant did not use any puffs of rescue medication during daytime and night-time.
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Timepoint [20]
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Baseline, 26 weeks, 52 weeks
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Secondary outcome [21]
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Asthma Quality of Life Questionnaire (AQLQ) at Week 52
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Assessment method [21]
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AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). It consists of 4 domains:
Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items)
Activity limitation = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items)
Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items)
Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items)
Overall Score = Mean of Items 1 to 32 (32 items) The overall AQLQ score reported below is the mean of all 32 responses and ranges from 1 to 7, where higher scores indicate better quality of life.
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Timepoint [21]
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52 weeks
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Secondary outcome [22]
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Pre-dose FEV1 at Weeks 4 and 12
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Assessment method [22]
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Pre-dose FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
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Timepoint [22]
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4 weeks, 12 weeks
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Secondary outcome [23]
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Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes
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Assessment method [23]
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A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee.
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Timepoint [23]
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Up to Week 52
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Eligibility
Key inclusion criteria
- Patients with a diagnosis of asthma, (GINA 2015) for a period of at least 1 year prior
to Visit 1 (Screening).
- Patients who have used medium or high dose of ICS/LABA combinations for asthma for at
least 3 months and at stable medium or high doses of ICS/LABA for at least 1 month
prior to Visit 1.
- Patients must be symptomatic at screening despite treatment with mid or high stable
doses of ICS/LABA. Patients with ACQ-7 score = 1.5 at Visit 101 and at Visit 102
(before randomization).
- Patients with documented history of at least one asthma exacerbation which required
medical care from a physician, ER visit (or local equivalent structure) or
hospitalization in the 12 months prior to Visit 1, and required systemic
corticosteroid treatment.
- Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient
according to ATS/ERS guidelines after withholding bronchodilators at both visits 101
and 102.
- Withholding period of bronchodilators prior to spirometry: SABA for = 6 hrs, Twice
daily LABA (or FDC of ICS/LABA) for = 12 hrs, Once daily LABA (or FDC of ICS/LABA) for
= 24 hrs, SAMA for = 8 hrs, Short acting xanthines for 12 hrs, Long acting xanthines
for 24 hrs, .
- Washout period of each drug should be kept as close as possible as above and should
not be longer. If longer washout period is needed due to scheduling issues, please
contact Novartis Medical monitor.
- A one-time repeat of percentage predicated FEV1 (Pre-bronchodilator) at Visit 101
and/or Visit 102 is allowed in an ad-hoc visit. Repeat of Visit 101 spirometry should
be done in an ad-hoc visit to be scheduled on a date that would provide sufficient
time to receive confirmation from the spirometry data central reviewer of the validity
of the assessment before randomization. Run-in medication should be dispensed once
spirometry assessment met inclusion criteria (ATS/ERS quality criteria, FEV1 %
predicted normal value, and reversibility) as per equipment
- A one-time rescreen is allowed in case the patient fails to meet the criteria at the
repeat, provided the patient returned to the required treatment as per inclusion
criteria 4
- Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after
administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit
101.All patients must perform a reversibility test at Visit 101. If reversibility is
not demonstrated at Visit 101 then one of the following criteria need to be met.
- Reversibility should be repeated once.
- Patients may be permitted to enter the study with historical evidence of reversibility
that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1.
- Alternatively, patients may be permitted to enter the study with a historical positive
bronchoprovocation test that was performed within 2 years prior to Visit 1. If
reversibility is not demonstrated at Visit 101 (or after repeated assessment in an
ad-hoc visit) and historical evidence of reversibility/bronchoprovocation is not
available (or was not performed according to the ATS/ERS guidelines patients must be
screen failed
- Spacer devices are permitted during reversibility testing only. The Investigator or
delegate may decide whether or not to use a spacer for the reversibility testing
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who have had an asthma attack/exacerbation requiring systemic steroids or
hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening). If
patients experience an asthma attack/exacerbation requiring systemic steroids or
hospitalization or emergency room visit between Visit 1 and Visit 102 they may be
re-screened 6 weeks after recovery from the exacerbation.
- Patients who have ever required intubation for a severe asthma attack/exacerbation.
- Patients who have a clinical condition which is likely to be worsened by ICS
administration (e.g. glaucoma, cataract and fragility fractures) who are according to
investigator's medical judgment at risk participating in the study.
- Patients treated with a LAMA for asthma within 3 months prior Visit 1 (Screening).
- Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or
bladder-neck obstruction or severe renal impairment or urinary retention. BPH patients
who are stable on treatment can be considered).
- Patients who have had a respiratory tract infection or asthma worsening as determined
by investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and
Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory
tract infection or asthma worsening.
- Patients with evidence upon visual inspection (laboratory culture is not required) of
clinically significant (in the opinion of investigator) oropharyngeal candidiasis at
Visit 102 or earlier, with or without treatment. Patients may be re-screened once
their candidiasis has been treated and has resolved.
- Patients with any chronic conditions affecting the upper respiratory tract (e.g.
chronic sinusitis) which in the opinion of the investigator may interfere with the
study evaluation or optimal participation in the study.
- Patients with a history of chronic lung diseases other than asthma, including (but not
limited to) chronic obstructive pulmonary disease, sarcoidosis, interstitial lung
disease, cystic fibrosis, clinically significant bronchiectasis and active
tuberculosis.
- Patients with Type I diabetes or uncontrolled Type II diabetes.
- Patients who, either in the judgment of the investigator or the responsible Novartis
personnel, have a clinically significant condition such as (but not limited to)
unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left
ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease,
psychiatric disease, neurodegenerative diseases, or other neurological disease,
uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia,
hyperadrenergic state, or ophthalmologic disorder or patients with a medical condition
that might compromise patient safety or compliance, interfere with evaluation, or
preclude completion of the study.
- Patients with paroxysmal (e.g., intermittent) atrial fibrillation are excluded.
Patients with persistent atrial fibrillation as defined by continuous atrial
fibrillation for at least 6 months and controlled with a rate control strategy (i.e.,
selective beta blockers, calcium channel blocker, pacemaker placement, digoxin or
ablation therapy) for at least 6 months may be considered for inclusion. In such
patients, atrial fibrillation must be present at the run-in visit (Visit 101) with a
resting ventricular rate < 100/min. At Visit 101 the atrial fibrillation must be
confirmed by central reading.
- Patients with a history of myocardial infarction (this should be confirmed clinically
by the investigator) within the previous 12 months.
- Concomitant use of agents known to prolong the QT interval unless it can be
permanently discontinued for the duration of study
- Patients with a history of long QT syndrome or whose QTc measured at Visit 101
(Fridericia method) is prolonged (> 450 msec for males and > 460 msec for females) and
confirmed by a central assessor (these patients should not be rescreened).
- Patients with a history of hypersensitivity to lactose, any of the study drugs or to
similar drugs within the class including untoward reactions to sympathomimetic amines
or inhaled medication or any component thereof.
- Patients who have not achieved an acceptable spirometry result at Visit 101 in
accordance with ATS/ERS criteria for acceptability and repeatability. A one-time
repeat spirometry is allowed in an ad-hoc visit scheduled as close as possible from
the first attempt (but not on the same day) if the spirometry did not qualify due to
ATS/ERS criteria at Visit 101 and/or Visit 102. If the patient fails the repeat
assessment, the patient may be rescreened once, provided the patient returns to the
required treatment as per inclusion criteria 4.
- Patients unable to use the Concept1 dry powder inhaler, Accuhaler or a metered dose
inhaler. Spacer devices are not permitted.
- History of alcohol or other substance abuse.
- Patients with a known history of non-compliance to medication or who were unable or
unwilling to complete a patient diary or who are unable or unwilling to use Electronic
Peak Flow with e-diary device.
- Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night
shift workers).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/12/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/06/2019
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Sample size
Target
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Accrual to date
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Final
3092
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
Argentina
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State/province [1]
0
0
Buenos Aires
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Country [2]
0
0
Argentina
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State/province [2]
0
0
Cordoba
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Country [3]
0
0
Argentina
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State/province [3]
0
0
Entre Rios
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Country [4]
0
0
Argentina
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State/province [4]
0
0
Mendoza
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Country [5]
0
0
Argentina
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State/province [5]
0
0
Rosario
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Country [6]
0
0
Argentina
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State/province [6]
0
0
Santa Fe
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Country [7]
0
0
Argentina
Query!
State/province [7]
0
0
Tucuman
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Parana
Query!
Country [9]
0
0
Austria
Query!
State/province [9]
0
0
Bludenz
Query!
Country [10]
0
0
Austria
Query!
State/province [10]
0
0
Feldbach
Query!
Country [11]
0
0
Austria
Query!
State/province [11]
0
0
Feldkirch
Query!
Country [12]
0
0
Austria
Query!
State/province [12]
0
0
Grieskirchen
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
BEL
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Brussel
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Braine L Alleud Waterloo
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Bruxelles
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Eghezee
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Erpent
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Lebbeke
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Liege
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Malmedy
Query!
Country [22]
0
0
Bulgaria
Query!
State/province [22]
0
0
BGR
Query!
Country [23]
0
0
Bulgaria
Query!
State/province [23]
0
0
Ruse
Query!
Country [24]
0
0
Bulgaria
Query!
State/province [24]
0
0
Sofia
Query!
Country [25]
0
0
Bulgaria
Query!
State/province [25]
0
0
Stara Zagora
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Alberta
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Ontario
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Quebec
Query!
Country [29]
0
0
Chile
Query!
State/province [29]
0
0
Region Metropolitana
Query!
Country [30]
0
0
Chile
Query!
State/province [30]
0
0
TX
Query!
Country [31]
0
0
Chile
Query!
State/province [31]
0
0
VII Region Del Maule
Query!
Country [32]
0
0
Chile
Query!
State/province [32]
0
0
Santiago
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Hainan
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Jiangsu
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Jilin
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Liaoning
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Shanghai
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Shanxi
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Sichuan
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Chongqing
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Tianjin
Query!
Country [42]
0
0
Colombia
Query!
State/province [42]
0
0
Bogota DC
Query!
Country [43]
0
0
Colombia
Query!
State/province [43]
0
0
Bogota
Query!
Country [44]
0
0
Colombia
Query!
State/province [44]
0
0
Floridablanca
Query!
Country [45]
0
0
Colombia
Query!
State/province [45]
0
0
Medellin
Query!
Country [46]
0
0
Croatia
Query!
State/province [46]
0
0
HRV
Query!
Country [47]
0
0
Croatia
Query!
State/province [47]
0
0
Petrinja
Query!
Country [48]
0
0
Croatia
Query!
State/province [48]
0
0
Zadar
Query!
Country [49]
0
0
Croatia
Query!
State/province [49]
0
0
Zagreb
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
Copenhagen NV
Query!
Country [51]
0
0
Denmark
Query!
State/province [51]
0
0
Hvidovre
Query!
Country [52]
0
0
Estonia
Query!
State/province [52]
0
0
Tallinn
Query!
Country [53]
0
0
Estonia
Query!
State/province [53]
0
0
Tartu
Query!
Country [54]
0
0
Finland
Query!
State/province [54]
0
0
Jyvaskyla
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Herault
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Nordrhein Westfalen
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
NRW
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Sachsen
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Schleswig Holstein
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Annaberg-Buchholz
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Aschaffenburg
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Berlin
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Bonn
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Darmstadt
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Frankfurt am Main
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Frankfurt
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Halle
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Hamburg
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Hannover
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Karlsruhe
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Leipzig
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Lübeck
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Mainz
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Mittweida
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Neu Isenburg
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Potsdam
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Rudersdorf
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Witten
Query!
Country [79]
0
0
Greece
Query!
State/province [79]
0
0
GR
Query!
Country [80]
0
0
Greece
Query!
State/province [80]
0
0
Athens
Query!
Country [81]
0
0
Greece
Query!
State/province [81]
0
0
Heraklion Crete
Query!
Country [82]
0
0
Hungary
Query!
State/province [82]
0
0
HUN
Query!
Country [83]
0
0
Hungary
Query!
State/province [83]
0
0
Balassagyarmat
Query!
Country [84]
0
0
Hungary
Query!
State/province [84]
0
0
Budapest
Query!
Country [85]
0
0
Hungary
Query!
State/province [85]
0
0
Godollo
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Komarom
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Mateszalka
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Nyiregyhaza
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Szarvas
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Szeged
Query!
Country [91]
0
0
Hungary
Query!
State/province [91]
0
0
Szigetszentmiklos
Query!
Country [92]
0
0
Hungary
Query!
State/province [92]
0
0
Szigetvar
Query!
Country [93]
0
0
India
Query!
State/province [93]
0
0
Andhra Pradesh
Query!
Country [94]
0
0
India
Query!
State/province [94]
0
0
Bihar
Query!
Country [95]
0
0
India
Query!
State/province [95]
0
0
Delhi
Query!
Country [96]
0
0
India
Query!
State/province [96]
0
0
Gujarat
Query!
Country [97]
0
0
India
Query!
State/province [97]
0
0
Haryana
Query!
Country [98]
0
0
India
Query!
State/province [98]
0
0
Karnataka
Query!
Country [99]
0
0
India
Query!
State/province [99]
0
0
Kerala
Query!
Country [100]
0
0
India
Query!
State/province [100]
0
0
Maharashtra
Query!
Country [101]
0
0
India
Query!
State/province [101]
0
0
Maharastra
Query!
Country [102]
0
0
India
Query!
State/province [102]
0
0
Punjab
Query!
Country [103]
0
0
India
Query!
State/province [103]
0
0
Rajasthan
Query!
Country [104]
0
0
India
Query!
State/province [104]
0
0
Tamil Nadu
Query!
Country [105]
0
0
India
Query!
State/province [105]
0
0
Telangana
Query!
Country [106]
0
0
India
Query!
State/province [106]
0
0
Uttar Pradesh
Query!
Country [107]
0
0
India
Query!
State/province [107]
0
0
Uttarakhand
Query!
Country [108]
0
0
India
Query!
State/province [108]
0
0
West Bengal
Query!
Country [109]
0
0
Ireland
Query!
State/province [109]
0
0
Cork
Query!
Country [110]
0
0
Ireland
Query!
State/province [110]
0
0
Dublin
Query!
Country [111]
0
0
Israel
Query!
State/province [111]
0
0
Ashkelon
Query!
Country [112]
0
0
Israel
Query!
State/province [112]
0
0
Beer-Sheva
Query!
Country [113]
0
0
Israel
Query!
State/province [113]
0
0
Jerusalem
Query!
Country [114]
0
0
Israel
Query!
State/province [114]
0
0
Kfar Saba
Query!
Country [115]
0
0
Israel
Query!
State/province [115]
0
0
Petach Tikva
Query!
Country [116]
0
0
Israel
Query!
State/province [116]
0
0
Rehovot
Query!
Country [117]
0
0
Israel
Query!
State/province [117]
0
0
Tel Giborim, Holon
Query!
Country [118]
0
0
Italy
Query!
State/province [118]
0
0
BA
Query!
Country [119]
0
0
Italy
Query!
State/province [119]
0
0
CT
Query!
Country [120]
0
0
Italy
Query!
State/province [120]
0
0
CZ
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
FI
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
ME
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
VR
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Ancona
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Messina
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Pordenone
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Roma
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Fukuoka
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Hokkaido
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Hyogo
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Ibaraki
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Kanagawa
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Mie
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Miyagi
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Okayama
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Osaka
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Shibuya Ku
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Shizuoka
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Tokyo
Query!
Country [140]
0
0
Jordan
Query!
State/province [140]
0
0
JOR
Query!
Country [141]
0
0
Latvia
Query!
State/province [141]
0
0
LVA
Query!
Country [142]
0
0
Latvia
Query!
State/province [142]
0
0
LV
Query!
Country [143]
0
0
Latvia
Query!
State/province [143]
0
0
Daugavpils
Query!
Country [144]
0
0
Latvia
Query!
State/province [144]
0
0
Riga
Query!
Country [145]
0
0
Lebanon
Query!
State/province [145]
0
0
LBN
Query!
Country [146]
0
0
Lebanon
Query!
State/province [146]
0
0
Ashrafieh
Query!
Country [147]
0
0
Lebanon
Query!
State/province [147]
0
0
Beirut
Query!
Country [148]
0
0
Lithuania
Query!
State/province [148]
0
0
LTU
Query!
Country [149]
0
0
Lithuania
Query!
State/province [149]
0
0
LT
Query!
Country [150]
0
0
Lithuania
Query!
State/province [150]
0
0
Kaunas
Query!
Country [151]
0
0
Lithuania
Query!
State/province [151]
0
0
Klaipeda
Query!
Country [152]
0
0
Lithuania
Query!
State/province [152]
0
0
Siauliai
Query!
Country [153]
0
0
Lithuania
Query!
State/province [153]
0
0
Vilnius
Query!
Country [154]
0
0
Mexico
Query!
State/province [154]
0
0
Jalisco
Query!
Country [155]
0
0
Mexico
Query!
State/province [155]
0
0
MEX
Query!
Country [156]
0
0
Mexico
Query!
State/province [156]
0
0
Nuevo Leon
Query!
Country [157]
0
0
Mexico
Query!
State/province [157]
0
0
Oaxaca
Query!
Country [158]
0
0
Mexico
Query!
State/province [158]
0
0
Veracruz
Query!
Country [159]
0
0
Netherlands
Query!
State/province [159]
0
0
CK
Query!
Country [160]
0
0
Netherlands
Query!
State/province [160]
0
0
Eindhoven
Query!
Country [161]
0
0
Netherlands
Query!
State/province [161]
0
0
Groningen
Query!
Country [162]
0
0
Netherlands
Query!
State/province [162]
0
0
Harderwijk
Query!
Country [163]
0
0
Netherlands
Query!
State/province [163]
0
0
Heerlen
Query!
Country [164]
0
0
Netherlands
Query!
State/province [164]
0
0
Helmond
Query!
Country [165]
0
0
Netherlands
Query!
State/province [165]
0
0
Hengelo
Query!
Country [166]
0
0
Netherlands
Query!
State/province [166]
0
0
Rotterdam
Query!
Country [167]
0
0
Netherlands
Query!
State/province [167]
0
0
Zutphen
Query!
Country [168]
0
0
Peru
Query!
State/province [168]
0
0
Lima
Query!
Country [169]
0
0
Philippines
Query!
State/province [169]
0
0
Batangas
Query!
Country [170]
0
0
Philippines
Query!
State/province [170]
0
0
Metro Manila
Query!
Country [171]
0
0
Philippines
Query!
State/province [171]
0
0
Bulacan
Query!
Country [172]
0
0
Philippines
Query!
State/province [172]
0
0
Manila
Query!
Country [173]
0
0
Philippines
Query!
State/province [173]
0
0
Quezon City
Query!
Country [174]
0
0
Poland
Query!
State/province [174]
0
0
POL
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Aleksandrow Odzki
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Bielsko-Biala
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Elblag
Query!
Country [178]
0
0
Poland
Query!
State/province [178]
0
0
Inowroclaw
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Krakow
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Lodz
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Ostrow Wielkopolski
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Sopot
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Wroclaw
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Zawadzkie
Query!
Country [185]
0
0
Portugal
Query!
State/province [185]
0
0
Coimbra
Query!
Country [186]
0
0
Portugal
Query!
State/province [186]
0
0
Lisboa
Query!
Country [187]
0
0
Portugal
Query!
State/province [187]
0
0
Porto
Query!
Country [188]
0
0
Romania
Query!
State/province [188]
0
0
ROM
Query!
Country [189]
0
0
Romania
Query!
State/province [189]
0
0
Timis
Query!
Country [190]
0
0
Romania
Query!
State/province [190]
0
0
Arad
Query!
Country [191]
0
0
Romania
Query!
State/province [191]
0
0
Bacau
Query!
Country [192]
0
0
Romania
Query!
State/province [192]
0
0
Brasov
Query!
Country [193]
0
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj Napoca
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Romania
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Cluj-Napoca
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Romania
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Constanta
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Romania
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Deva
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Romania
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Pitesti
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ivanovo
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Perm
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Russian Federation
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Pskov
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Russian Federation
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Pyatigorsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Sestroretsk
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Russian Federation
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Smolensk
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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Tver
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Russian Federation
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Ufa
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Russian Federation
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Ulyanovsk
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Russian Federation
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Vladikavkaz
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Russian Federation
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Volgograd
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Russian Federation
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Vsevolozhsk
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Russian Federation
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Yaroslavl
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Slovakia
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Slovak Republic
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Slovakia
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Kezmarok
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Slovakia
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Kosice
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Slovakia
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Liptovsky Mikulas
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Slovakia
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Poprad
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Slovakia
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Presov
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Slovakia
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Spisska Nova Ves
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Slovakia
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Trencin
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Slovakia
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Zilina
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Slovakia
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Zvolen
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South Africa
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Durban
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South Africa
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Kwazulu Natal
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South Africa
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ZAF
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South Africa
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Cape Town
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Spain
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Andalucia
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Castellon
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Spain
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Catalunya
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Spain
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Comunidad Valenciana
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Spain
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Extremadura
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Spain
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Santa Cruz De Tenerife
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Spain
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Leon
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Spain
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Zaragoza
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Sweden
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Lidingo
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Sweden
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Stockholm
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Switzerland
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Gossau
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Thailand
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Nonthaburi
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Thailand
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THA
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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United Kingdom
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East Yorkshire
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United Kingdom
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London
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United Kingdom
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Wiltshire
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Vietnam
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VNM
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Country [262]
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Vietnam
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Hanoi
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Country [263]
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0
Vietnam
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 µg and QVM149 150/50/160 µg via Concept1) over two respective QMF149 doses (QMF149 150/160 µg and QMF149 150/320) µg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02571777
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/ct2/show/NCT02571777
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