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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02224157
Registration number
NCT02224157
Ethics application status
Date submitted
19/08/2014
Date registered
25/08/2014
Date last updated
25/11/2019
Titles & IDs
Public title
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
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Scientific title
A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
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Secondary ID [1]
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0
2013-004473-28
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Secondary ID [2]
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D589SC00003
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Universal Trial Number (UTN)
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Trial acronym
SYGMA2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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0
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Condition category
Condition code
Respiratory
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0
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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 - budesonide/formoterol 'as needed' + budesonide placebo bid
Treatment: Drugs - budesonode bid + terbutaline 'as needed'
Experimental: Symbicort "as needed"+placebo Pulmicort bid - Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 µg 'as needed' + Placebo Pulmicort Turbuhaler 200 µg bid
Active comparator: Pulmicort bid + terbutaline "as needed" - Pulmicort 200 µg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
Treatment: Drugs: budesonide/formoterol 'as needed' + budesonide placebo bid
Symbicort (budesonide/ formoterol) 160/4.5 µg powder for inhalation 'as needed' plus Pulmicort placebo 200 µg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
Treatment: Drugs: budesonode bid + terbutaline 'as needed'
Pulmicort (budesonide) 200 µg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
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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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Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis
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Assessment method [1]
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Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation
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Timepoint [1]
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up to 52 weeks
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Primary outcome [2]
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Annual Severe Asthma Exacerbation Rate - Superiority Analysis
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Assessment method [2]
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Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation
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Timepoint [2]
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up to 52 weeks
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Secondary outcome [1]
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Number of Participants Experiencing at Least One Severe Asthma Exacerbation
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Assessment method [1]
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A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids.
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Timepoint [1]
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Day 1 up to 52 weeks
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Secondary outcome [2]
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Average Change From Baseline in Pre-bronchodilator FEV1
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Assessment method [2]
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The average change from baseline (baseline defined by measurement at week 0, prior to first dose of IP) to the treatment period average assessed over the entire treatment period in pre-bronchodilator FEV1 was derived by computing a contrast for the mean across the post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
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Timepoint [2]
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Study weeks 0,17, 34, 52
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Secondary outcome [3]
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Number of Participants With Study Specific Asthma Related Discontinuation
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Assessment method [3]
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The following two criteria lead to discontinuation from the IP due to asthma related events: A severe asthma exacerbation with duration for more than 3 weeks, and/or three severe asthma exacerbations during 6 months.
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Timepoint [3]
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Day 1 up to 52 weeks
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Secondary outcome [4]
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Average Change From Baseline in 'as Needed' Use
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Assessment method [4]
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'As-needed' use change from baseline over the randomised treatment period. Baseline was defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as-needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day.
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Timepoint [4]
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Week 0 up to 52 weeks
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Secondary outcome [5]
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Change From Baseline in Percent of 'as Needed' Free Days
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Assessment method [5]
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'As needed' free days (%) change from baseline during randomised treatment period. An 'as-needed' free day was defined as a day and night with no use of 'as needed' medication. Variable analysed is the percentage (%) of 'as-needed' free days during the randomised treatment period. Baseline is defined by the last 10 days of the run-in period.
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Timepoint [5]
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Week 0 up to 52 weeks
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Secondary outcome [6]
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Percentage of Controller Use Days
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Assessment method [6]
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ICS controller use days (%) during the randomised treatment period is calculated as the cumulative days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma (all treatment groups), divided by the number of days in the randomised treatment period.
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Timepoint [6]
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Week 0 up to 52 weeks
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Secondary outcome [7]
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Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score
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Assessment method [7]
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ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided. The average change from baseline to treatment period average in ACQ-5 was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
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Timepoint [7]
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Study weeks 0, 17, 34, 52
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Secondary outcome [8]
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Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score
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Assessment method [8]
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AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items. The average change from baseline to treatment period average in AQLQ(S) overall score was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.
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Timepoint [8]
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Study weeks 0,17, 34, 52
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Eligibility
Key inclusion criteria
1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required
2. Male or Female, =12 years of age
3. Documented diagnosis of asthma for at least 6 months prior to Visit 1
4. Patients who are in need of GINA step 2 treatment
5. Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 = 60 % of predicted normal (PN) and post-bronchodilator FEV1 = 80 % PN
6. Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 =80 % PN
7. Patients should have reversible airway obstruction
8. To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period
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Minimum age
12
Years
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Maximum age
130
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
1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission
2. Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
3. Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
4. Current or previous smoker with a smoking history of = 10 pack years
5. Pregnancy, breast-feeding or planned pregnancy during the study
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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 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
28/11/2014
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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
16/08/2017
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Sample size
Target
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Accrual to date
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Final
4215
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Sydney
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment outside Australia
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Brazil
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Botucatu
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Brazil
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Florianopolis
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Goiania
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Porto Alegre
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Salvador
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Brazil
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Sorocaba
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Brazil
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São Paulo
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Bulgaria
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Blagoevgrad
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Bulgaria
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Pernik
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Bulgaria
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Petrich
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'
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Trial website
https://clinicaltrials.gov/study/NCT02224157
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Trial related presentations / publications
FitzGerald JM, O'Byrne PM, Bateman ED, Barnes PJ, Zheng J, Ivanov S, Lamarca R, Larsdotter U, Emerath U, Jansen G, Puu M, Alagappan VKT, Surmont F, Reddel HK. Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies. Drug Saf. 2021 Apr;44(4):467-478. doi: 10.1007/s40264-020-01041-z. Epub 2021 Feb 6. Bateman ED, Reddel HK, O'Byrne PM, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Siwek-Posluszna A, FitzGerald JM. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1877-1887. doi: 10.1056/NEJMoa1715275. O'Byrne PM, FitzGerald JM, Zhong N, Bateman E, Barnes PJ, Keen C, Almqvist G, Pemberton K, Jorup C, Ivanov S, Reddel HK. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials. Trials. 2017 Jan 10;18(1):12. doi: 10.1186/s13063-016-1731-4. Reddel HK, Busse WW, Pedersen S, Tan WC, Chen YZ, Jorup C, Lythgoe D, O'Byrne PM. Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study. Lancet. 2017 Jan 14;389(10065):157-166. doi: 10.1016/S0140-6736(16)31399-X. Epub 2016 Nov 30.
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Public notes
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Contacts
Principal investigator
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Carin Jorup, MD
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AstraZeneca Research & Development
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/57/NCT02224157/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/57/NCT02224157/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02224157
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