A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

ID: NCT03034915
Status: Active, not recruiting
Phase: Phase 4
Start Date: June 16, 2017
First Submitted: January 25, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: GlaxoSmithKline
Sponsors & Collaborators: GlaxoSmithKline
Location: Argentina, Australia, Canada, France, Germany, Italy, Mexico, Netherlands, South Africa, Spain, Sweden, United States
Conditions: Pulmonary Disease, Chronic Obstructive
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

Brief Summary

COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations, and also to improve health status and exercise tolerance.

This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5 mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD. The primary purpose of this study is to demonstrate improvements in lung function for subjects treated with UMEC/VI compared with UMEC for 24 weeks.

Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio. Subjects will be stratified based on long-acting bronchodilator usage during the run-in period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA® dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week.

ELLIPTA and DISKUS are trademarks of GSK group of companies.

Detailed Description

Condition or disease Intervention/treatment Phase

Pulmonary Disease, Chronic Obstructive

Drug: UMEC/VI 62.5/25 mcg via ELLIPTA
Other Names
Drug: UMEC 62.5 mcg via ELLIPTA
Other Names
Drug: Salmeterol 50 mcg via DISKUS
Other Names
Drug: Placebo via ELLIPTA
Other Names
Drug: Placebo via DISKUS
Other Names
Phase 4

Tracking Information

First Submitted DateJanuary 25, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateJune 16, 2017
Anticipated Completion DateJune 18, 2018
Actual Primary Completion DateJune 18, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change from Baseline in trough forced expiratory volume in one second (FEV1) [Time Frame: Baseline and Week 24]

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 24 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 167 (Week 24).

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Change from Baseline in self-administered computerised (SAC) transient dyspnea index (TDI) [Time Frame: Baseline and at Week 4, Week 12 and Week 24]

    The TDI measures changes in the subject's dyspnea from Baseline. SAC TDI provides a continuous measure of change in dyspnea using a visual analogue scale to record responses. The score depends on ratings for three different categories: functional impairment, magnitude of task, and magnitude of effort. Questionnaires will be completed at clinic visits and in the electronic diary. SAC TDI will be used to measure the change from Baseline (SAC BDI) at Weeks 4, 12 and 24.

  • Number of TDI responders according to SAC TDI score [Time Frame: Up to 24 weeks]

    A responder is defined as a >=1 unit improvement in SAC TDI score. Responder analyses will be done to provide comparative data between the treatment groups.

  • Total scores of respiratory Symptoms (E-RS)-COPD and its subscales: breathlessness, cough and sputum and chest symptoms [Time Frame: Up to 24 weeks]

    The E-RS: COPD is an 11-item scoring instrument, intended to capture information related to the respiratory symptoms of COPD, i.e., breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS: COPD has a scoring range of 0-40, where higher scores indicate more severe symptoms. Three subscales of the E-RS: COPD are used to describe different symptoms: dyspnea, cough and sputum and chest symptoms. ER-S: COPD is completed daily approximately 2 hours before bed-time from screening until the last clinic visit.

  • Number of E-RS responders according to E-RS score [Time Frame: Up to 24 weeks]

    A responder is defined as reduction in E-RS score of >=2 or >=3.35 units from Baseline.

  • Change from Baseline in St George's respiratory questionnaire-chronic obstructive pulmonary disease specific (SGRQ-C) [Time Frame: Baseline and at Week 4, Week 12 and Week 24]

    SGRQ-C measures the impact of respiratory disease and its treatment on HRQoL of an individual with COPD. Total score as well as the individual domain scores: symptoms, activity and impacts will be produced. SGRQ-C will be completed by subjects at Baseline (Day 1) and at Weeks 4, 12 and 24.

  • Number of responders according to SGRQ-C total score [Time Frame: Week 4, Week 12 and Week 24]

    A responder is defined as a 4 point or greater reduction from Baseline in SGRQ-C total score. SGRQ-C will be completed by subjects at Baseline (Day 1) and at Weeks 4, 12 and 24.

  • Change from Baseline in COPD assessment test (CAT) [Time Frame: Baseline and at Week 4, Week 12 and Week 24]

    The CAT is an 8-item questionnaire used to measure the health status of subjects with COPD. Subjects will rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact. CAT will be completed by subjects at Screening, Baseline (Day 1) and at Weeks 4, 12 and 24.

  • Number of responders according to CAT [Time Frame: Week 4, Week 12 and Week 24]

    A responder is defined as a >=2 unit improvement in score from Baseline. CAT will be completed by subjects at Screening, Baseline (Day 1) and at Weeks 4, 12 and 24.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Official TitleA 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary

COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations, and also to improve health status and exercise tolerance.

This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5 mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD. The primary purpose of this study is to demonstrate improvements in lung function for subjects treated with UMEC/VI compared with UMEC for 24 weeks.

Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio. Subjects will be stratified based on long-acting bronchodilator usage during the run-in period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA® dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week.

ELLIPTA and DISKUS are trademarks of GSK group of companies.

Detailed Description

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
960
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Pulmonary Disease, Chronic Obstructive
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: UMEC/VI 62.5/25 mcg via ELLIPTA

ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; the first strip contains umeclidinium bromide (62.5 mcg per blister) blended with lactose monohydrate and magnesium stearate and second strip contains vilanterol trifenatae (25 mcg per blister) blended with lactose monohydrate and magnesium stearate.

Other Names
Drug: UMEC 62.5 mcg via ELLIPTA

The ELLIPTA inhaler will contain one blister strip, which will have 30 blisters of umeclidinium bromide (62.5 mcg).

Other Names
Drug: Salmeterol 50 mcg via DISKUS

The DISKUS inhaler will contain one blister strip, which will have 60 blisters of salmeterol xinafoate (50 mcg). The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.

Other Names
Drug: Placebo via ELLIPTA

Lactose dry powder will be administered using ELLIPTA for both treatment periods. ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; containing lactose dry powder.

Other Names
Drug: Placebo via DISKUS

Lactose dry powder will be administered using DISKUS for both treatment periods. The DISKUS inhaler will contain one blister strip, which will have 60 blisters of lactose dry powder. The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.

Other Names
Study Groups/Cohorts
UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC/VI 62.5/25 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.

UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC 62.5 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.

Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA
Subjects will be instructed to self-administer one dose of salmeterol 50 mcg twice daily (morning and evening) via DISKUS DPI and placebo once daily morning via ELLIPTA DPI.

Study Arms
Experimental Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA
Subjects will be instructed to self-administer one dose of salmeterol 50 mcg twice daily (morning and evening) via DISKUS DPI and placebo once daily morning via ELLIPTA DPI.
Drug : Salmeterol 50 mcg via DISKUS
The DISKUS inhaler will contain one blister strip, which will have 60 blisters of salmeterol xinafoate (50 mcg). The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.

Experimental Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA
Subjects will be instructed to self-administer one dose of salmeterol 50 mcg twice daily (morning and evening) via DISKUS DPI and placebo once daily morning via ELLIPTA DPI.
Drug : Placebo via ELLIPTA
Lactose dry powder will be administered using ELLIPTA for both treatment periods. ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; containing lactose dry powder.

Experimental UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC 62.5 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
Drug : Placebo via DISKUS
Lactose dry powder will be administered using DISKUS for both treatment periods. The DISKUS inhaler will contain one blister strip, which will have 60 blisters of lactose dry powder. The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.

Experimental UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC 62.5 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
Drug : UMEC 62.5 mcg via ELLIPTA
The ELLIPTA inhaler will contain one blister strip, which will have 30 blisters of umeclidinium bromide (62.5 mcg).

Experimental UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC/VI 62.5/25 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
Drug : UMEC/VI 62.5/25 mcg via ELLIPTA
ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; the first strip contains umeclidinium bromide (62.5 mcg per blister) blended with lactose monohydrate and magnesium stearate and second strip contains vilanterol trifenatae (25 mcg per blister) blended with lactose monohydrate and magnesium stearate.

Experimental UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC/VI 62.5/25 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
Drug : Placebo via DISKUS
Lactose dry powder will be administered using DISKUS for both treatment periods. The DISKUS inhaler will contain one blister strip, which will have 60 blisters of lactose dry powder. The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.

Arm Intervention/Treatment
Experimental Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA
Subjects will be instructed to self-administer one dose of salmeterol 50 mcg twice daily (morning and evening) via DISKUS DPI and placebo once daily morning via ELLIPTA DPI.
Drug : Salmeterol 50 mcg via DISKUS
Experimental Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA
Subjects will be instructed to self-administer one dose of salmeterol 50 mcg twice daily (morning and evening) via DISKUS DPI and placebo once daily morning via ELLIPTA DPI.
Drug : Placebo via ELLIPTA
Experimental UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC 62.5 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
Drug : Placebo via DISKUS
Experimental UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC 62.5 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
Drug : UMEC 62.5 mcg via ELLIPTA
Experimental UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC/VI 62.5/25 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
Drug : UMEC/VI 62.5/25 mcg via ELLIPTA
Experimental UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC/VI 62.5/25 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
Drug : Placebo via DISKUS

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment960
Completion DateJune 18, 2018
Eligibility Criteria: Inclusion Criteria
- 40 years or older at date of signing informed consent at Screening Visit 1
- Outpatient with a diagnosis of COPD
- Persistent airflow limitations as indicated by a pre and post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a post-albuterol/salbutamol FEV1 of >=30% to <=80% predicted normal values at Screening Visit 1.
- A CAT score of >=10 at Screening Visit 1
- Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years (number of pack years = [number of cigarettes per day / 20] multiplied by number of years smoked [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack-years]). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack-year history.
- Male and female subjects are eligible to participate in the study. A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin test), not lactating, and at least one of the following conditions applies: non-reproductive potential defined as pre-menopausal females with documented tubal ligation or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion or hysterectomy or documented bilateral oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases, a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause must be tested. 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.
A female subject with reproductive potential is eligible to participate if she is not pregnant and agrees to follow one of the highly effective methods for avoiding pregnancy in females of reproductive potential from 30 days prior to the first dose of study medication and until (at least five terminal half-lives or until any continuing pharmacologic effect has ended, whichever is longer) after the last dose of study medication and completion of the follow-up visit. The investigator is responsible for ensuring that subjects understand how to properly use methods of contraception.
- Capable of giving signed informed consent prior to study participation.
Exclusion criteria
- 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).
- Subjects with known alpha-antitrypsin deficiency as the underlying cause of COPD
- 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.
- Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease as per investigator assessment); 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 or positive hepatitis C antibody test result or within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry criteria.
- Subjects with unstable or life threatening cardiac disease. The investigational product should be used with caution in subjects with severe cardiovascular disease. In the opinion of the investigator, use will only be considered if the benefit is likely to outweigh the risk in conditions such as myocardial infarction or unstable angina in the last 6 months, or unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months, or New York Heart Association Class IV heart failure.
- The investigator will determine the clinical significance of each abnormal electrocardiogram (ECG) finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. Subjects with the following abnormalities are excluded from participation in the study: atrial fibrillation with rapid ventricular rate >120 beats per minute (bpm), sustained or non-sustained ventricular tachycardia, second degree heart block Mobitz type II or third degree heart block (unless pacemaker or defibrillator had been inserted).
- Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction will be excluded unless, in the opinion of the study physician, the benefit outweighs the risk.
- Any subject who is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediate life-threatening illness (e.g., cancer). In addition, any subject who has any other condition (e.g., neurological condition) that is likely to affect respiratory function will not be included in the study.
- Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening Visit 1and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable).
- Subjects who had received inhaled corticosteroids (ICS) or ICS/ long-acting beta-agonist for the treatment of COPD in the 6 weeks prior to Screening Visit1.
- Subjects who had >1 moderate exacerbation in the 12 months prior to Screening Visit 1, or one severe exacerbation requiring hospitalization in the 12 months prior to Screening Visit 1.
- Other respiratory tract infections that have not resolved at least 7 days prior to Screening Visit 1.
- Subjects with lung volume reduction surgery (including procedures such as endobronchial valves) within the 12 months prior to Screening Visit 1.
- Use of long-term oxygen therapy described as resting oxygen therapy >3 Liter (L)/minute (min) at screening required to maintain adequate oxygenation (e.g., oxygen saturation in arterial blood [SaO2] >90%; oxygen use <=3 L/min flow is not exclusionary, and subjects may adjust oxygen levels up or down as needed during the study.)
- Use of ICS within 6 weeks prior to Screening Visit 1; use of depot corticosteroids within 12 weeks prior to Screening Visit 1; use of systemic, oral or parenteral corticosteroids within 6 weeks prior to Screening Visit 1 (Localized corticosteroid injections [e.g., intra-articular and epidural] are permitted); use of antibiotics (for lower respiratory tract infection) within 6 weeks prior to Screening Visit 1; use of phosphodiesterase 4 (PDE4) inhibitor (e.g., roflumilast) within 14 days prior to Screening Visit 1; use of long-acting beta-agonist/ ICS combination products within 6 weeks prior to Screening Visit 1; use of theophyllines within 48 hours prior to Screening Visit 1; use of oral long-acting beta2-agonists within 48 hours and short-acting beta2-agonists within 12 hours prior to Screening Visit 1; use of inhaled short-acting beta2-agonists within 4 hours prior to Screening Visit 1 (use of study provided albuterol/salbutamol is permitted during the study, except in the 4-hour period prior to spirometry testing); use of inhaled short-acting anticholinergics within 4 hours prior to Screening Visit 1; use of inhaled short-acting anticholinergic/short-acting beta2-agonist combination products within 4 hours prior to Screening Visit 1; use of any other investigational medication within 30 days or within 5 drug half-lives (whichever is longer) prior to Screening Visit 1.
- Subject unable to withhold albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit.
- Regular use (prescribed for daily/ regular use, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol).
- A known or suspected history of alcohol or drug abuse within 2 years prior to Screening Visit 1 that in the opinion of the investigator would prevent the subject from completing the study procedures.
- Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, sympathomimetic, lactose/milk protein or magnesium stearate.
- Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
- Subject is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
- In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete questionnaires on the electronic diary.
GenderAll
Age40 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Argentina
Australia
Canada
France
Germany
Italy
Mexico
Netherlands
South Africa
Spain
Sweden
United States

Administrative Information

NCT Number:NCT03034915
Other Study ID Numbers
201749
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
GlaxoSmithKline
Collaborators
Not Available
Investigators
Study Director
GSK Clinical Trials
GlaxoSmithKline