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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02729051




Registration number
NCT02729051
Ethics application status
Date submitted
31/03/2016
Date registered
6/04/2016

Titles & IDs
Public title
Comparative Study of Fluticasone Furoate(FF)/Umeclidinium Bromide (UMEC)/ Vilanterol (VI) Closed Therapy Versus FF/VI Plus UMEC Open Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Phase IIIB, 24-week Randomised, Double-blind Study to Compare 'Closed' Triple Therapy (FF/UMEC/VI) With 'Open' Triple Therapy (FF/VI + UMEC), in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
2015-005212-14
Secondary ID [2] 0 0
200812
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FF/UMEC/VI
Treatment: Drugs - FF/VI
Treatment: Drugs - UMEC
Treatment: Drugs - Placebo
Treatment: Drugs - Albuterol/salbutamol

Experimental: FF/UMEC/VI closed triple therapy plus Placebo - Subjects will receive FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg and placebo inhalation powder via the dry powder inhaler (DPI), once daily in the morning. Subjects will also receive albuterol/salbutamol as a rescue medication when needed during the treatment period.

Active comparator: FF/VI plus UMEC open triple therapy - Subjects will receive FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg inhalation powder via the DPI, once daily in the morning. Subjects will also receive albuterol/salbutamol as a rescue medication when needed during the treatment period.


Treatment: Drugs: FF/UMEC/VI
This intervention is provided in two strips. First strip contains FF blended with lactose. It is available as dry white powder, 100 mcg per blister. Second strip contains UMEC and VI blended with lactose and magnesium stearate. It is available as dry white powder, 62.5 mcg per blister UMEC, 25 mcg per blister VI. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (2 strips with 30 blisters per strip).

Treatment: Drugs: FF/VI
This intervention is provided in two strips. First strip contains FF blended with lactose. It is available as dry white powder, 100 mcg per blister. Second strip contains VI blended with lactose and magnesium stearate. It is available as dry white powder, 25 mcg per blister. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (2 strips with 30 blisters per strip).

Treatment: Drugs: UMEC
This intervention is available in one strip. The strip contains UMEC blended with lactose and magnesium stearate. The formulation is available as dry white powder, 62.5 mcg per blister. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (1 strip with 30 blisters).

Treatment: Drugs: Placebo
This intervention is available in one strip. The strip contains lactose. The formulation is available as dry white powder. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (1 strip with 30 blisters).

Treatment: Drugs: Albuterol/salbutamol
This is a rescue medication administered via metered-dose inhaler (MDI) with a spacer which will be used when needed during the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Percentage of Responders Based on the Saint (St) George Respiratory Questionnaire (SGRQ) Total Score at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Change From Baseline in SGRQ Total Score at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Percentage of Responders Based on Transitional Dyspnea Index (TDI) Focal Score at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
TDI Focal Score at Week 24
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Time to First Moderate or Severe Exacerbation
Timepoint [5] 0 0
Up to 25 weeks

Eligibility
Key inclusion criteria
Informed Consent: A signed and dated written informed consent prior to study participation.

* Type of subject: Outsubject.
* Age: Subjects 40 years of age or older at Screening (Visit 1).
* Gender: Male or female subjects. A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies:

Non-reproductive potential defined as:

* Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy.
* Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study treatmentand until after the last dose of study treatmentand completion of the follow-up visit.

* COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
* Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening (Visit 1) [number of pack years = (number of cigarettes per day divided by 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Screening (Visit 1). Note: Pipe and/or cigar use cannot be used to calculate pack-year history.
* Severity of COPD symptoms: A score of >=10 on the COPD Assessment Test (CAT) at Screening (Visit1).
* Severity of COPD Disease: A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 at Screening (Visit 1).
* Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening (Visit 1). Note: Subjects receiving only as needed COPD medications are not eligible.
* History of Exacerbations: Subjects must demonstrate: a post-bronchodilator FEV1 <50 percent predicted normal at Screening (Visit 1) and a documented history of >=1 moderate or severe COPD exacerbation in the 12 months prior to Screening or a post-bronchodilator 50 percent =< FEV1 <80 percent predicted normal at Screening (Visit 1) and a documented history of >=2 moderate exacerbations or a documented history of >=1 severe COPD exacerbation (hospitalised) in the 12 months prior to Screening (Visit 1). Notes: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations; A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalisation (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnoea, sputum volume, or sputum purulence (colour). Subject verbal reports are not acceptable.
* French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
* Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD, which is the primary cause of their respiratory symptoms).
* Alpha 1-antitrypsin deficiency: Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD.
* Other respiratory disorders: Subjects with active tuberculosis are excluded. Subjects with other respiratory disorders (e.g. clinically significant: bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases) are excluded if these conditions are the primary cause of their respiratory symptoms.
* Lung resection: Subjects with lung volume reduction surgery (including procedures such as endobronchial valves) within the 12 months prior to Screening (Visit 1).
* Risk Factors for Pneumonia: immune suppression (e.g. advanced human immune deficiency virus (HIV) with high viral load and low cluster of differentiation 4 (CD4) count, Lupus on immunosuppressants that would increase risk of pneumonia) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Notes: Subjects at a high risk for pneumonia (e.g. very low body mass index (BMI), severely malnourished or very low FEV1) will only be included at the discretion of the investigator.
* Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening (Visit 1) and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable).
* Other Respiratory tract infections that have not resolved at least 7 days prior to Screening (Visit 1).
* Abnormal Chest x-ray: Chest x-ray reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest x-ray (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening (Visit 1) [or historical radiograph or computerised tomography (CT) scan obtained within 3 months prior to Screening (Visit 1). Notes: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of Screening (Visit 1) must provide a post pneumonia/exacerbation chest x-ray or have a chest x-ray conducted at Screening (Visit 1); For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (BFS).
* Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
* Unstable liver disease: ALT >2 times upper limit of normal (ULN); and bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent). Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). Notes: Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis; Chronic stable hepatitis B and C (e.g., presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry criteria.
* Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class 4 Heart failure.
* Abnormal and clinically significant 12-Lead ECG finding: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: atrial fibrillation (AF) with rapid ventricular rate >120 beats per minute (BPM); sustained or nonsustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted).
* Contraindications: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator contraindicates study participation.
* Cancer: Subjects with carcinoma that has not been in complete remission for at least 3 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 3 year waiting period if the subject has been considered cured by treatment.
* Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 Liters per minute (Oxygen use <= 3 Liters/minute flow is not exclusionary.)
* Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit.
* Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
* Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
* Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
* Affiliation with investigator site: Study investigators, sub-investigators, and study coordinators, employees of a participating investigator or study site, or immediate family members of the aforementioned that is involved with this study.
* Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.
* Medication prior to Screening: Use of the following medications within 30 days prior to Screening (Visit 1) or requirement for their use during the study: Use of long term continuous antibiotic therapy; systemic, oral, parenteral corticosteroids (Intra-spinal and intra-articular injections are allowed); use of any other investigational drug: within 30 days or 5 half lives whichever is longer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/05/2017
Sample size
Target
Accrual to date
Final
1055
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - Maroubra
Recruitment hospital [3] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [4] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [5] 0 0
GSK Investigational Site - Woodville South
Recruitment hospital [6] 0 0
GSK Investigational Site - Footscray
Recruitment hospital [7] 0 0
GSK Investigational Site - Murdoch
Recruitment hospital [8] 0 0
GSK Investigational Site - Golden Beach
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
4551 - Golden Beach
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autónoma de Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Mendoza
Country [4] 0 0
Argentina
State/province [4] 0 0
San Miguel de Tucumán
Country [5] 0 0
France
State/province [5] 0 0
Brest Cedex
Country [6] 0 0
France
State/province [6] 0 0
Marseille cedex 03
Country [7] 0 0
France
State/province [7] 0 0
Nantes cedex 2
Country [8] 0 0
France
State/province [8] 0 0
Perpignan
Country [9] 0 0
France
State/province [9] 0 0
Pringy Cedex
Country [10] 0 0
France
State/province [10] 0 0
Toulouse
Country [11] 0 0
Germany
State/province [11] 0 0
Bayern
Country [12] 0 0
Germany
State/province [12] 0 0
Brandenburg
Country [13] 0 0
Germany
State/province [13] 0 0
Hessen
Country [14] 0 0
Germany
State/province [14] 0 0
Niedersachsen
Country [15] 0 0
Germany
State/province [15] 0 0
Nordrhein-Westfalen
Country [16] 0 0
Germany
State/province [16] 0 0
Sachsen
Country [17] 0 0
Italy
State/province [17] 0 0
Campania
Country [18] 0 0
Italy
State/province [18] 0 0
Emilia-Romagna
Country [19] 0 0
Italy
State/province [19] 0 0
Sicilia
Country [20] 0 0
Italy
State/province [20] 0 0
Toscana
Country [21] 0 0
Italy
State/province [21] 0 0
Umbria
Country [22] 0 0
Japan
State/province [22] 0 0
Aichi
Country [23] 0 0
Japan
State/province [23] 0 0
Chiba
Country [24] 0 0
Japan
State/province [24] 0 0
Ehime
Country [25] 0 0
Japan
State/province [25] 0 0
Fukuoka
Country [26] 0 0
Japan
State/province [26] 0 0
Gifu
Country [27] 0 0
Japan
State/province [27] 0 0
Gunma
Country [28] 0 0
Japan
State/province [28] 0 0
Hokkaido
Country [29] 0 0
Japan
State/province [29] 0 0
Hyogo
Country [30] 0 0
Japan
State/province [30] 0 0
Ibaraki
Country [31] 0 0
Japan
State/province [31] 0 0
Ishikawa
Country [32] 0 0
Japan
State/province [32] 0 0
Kagawa
Country [33] 0 0
Japan
State/province [33] 0 0
Kanagawa
Country [34] 0 0
Japan
State/province [34] 0 0
Kyoto
Country [35] 0 0
Japan
State/province [35] 0 0
Mie
Country [36] 0 0
Japan
State/province [36] 0 0
Niigata
Country [37] 0 0
Japan
State/province [37] 0 0
Okayama
Country [38] 0 0
Japan
State/province [38] 0 0
Osaka
Country [39] 0 0
Japan
State/province [39] 0 0
Shizuoka
Country [40] 0 0
Japan
State/province [40] 0 0
Tokyo
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Suwon
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Wonju, Gangwon-do,
Country [44] 0 0
Mexico
State/province [44] 0 0
Estado De México
Country [45] 0 0
Mexico
State/province [45] 0 0
Jalisco
Country [46] 0 0
Mexico
State/province [46] 0 0
Nuevo León
Country [47] 0 0
Mexico
State/province [47] 0 0
Aguascalientes
Country [48] 0 0
Mexico
State/province [48] 0 0
México DF
Country [49] 0 0
Poland
State/province [49] 0 0
Elblag
Country [50] 0 0
Poland
State/province [50] 0 0
Grudziadz
Country [51] 0 0
Poland
State/province [51] 0 0
Kielce
Country [52] 0 0
Poland
State/province [52] 0 0
Krakow
Country [53] 0 0
Poland
State/province [53] 0 0
Ostrow Wilekopolski
Country [54] 0 0
Poland
State/province [54] 0 0
Tarnów
Country [55] 0 0
Romania
State/province [55] 0 0
Bucharest
Country [56] 0 0
Romania
State/province [56] 0 0
Cluj Napoca
Country [57] 0 0
Romania
State/province [57] 0 0
Ramnicu Valcea
Country [58] 0 0
Romania
State/province [58] 0 0
Suceava
Country [59] 0 0
Romania
State/province [59] 0 0
Targu Mures
Country [60] 0 0
Romania
State/province [60] 0 0
Timisoara
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Arkhangelsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Barnaul
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Irkutsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Izhevsk
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Kazan
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Novosibirsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Saint Petesburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Saint-Petersburg
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Saratov
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Tomsk
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Ufa
Country [73] 0 0
Spain
State/province [73] 0 0
Cantabria
Country [74] 0 0
Spain
State/province [74] 0 0
Barcelona
Country [75] 0 0
Spain
State/province [75] 0 0
Mérida (Badajoz)
Country [76] 0 0
Spain
State/province [76] 0 0
Pamplona
Country [77] 0 0
Spain
State/province [77] 0 0
Pozuelo De Alarcón/Madrid
Country [78] 0 0
Spain
State/province [78] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02729051