Last updated: 11/07/2018 09:29:25
Evaluate the Efficacy and Safety of GSK573719 Delivered via a Novel Dry Powder Inhaler in Subjects with COPD
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease
Trial description: The purpose of this study is to assess if 12 weeks’ treatment with GSK573719 Inhalation Powder is safe and effective compared with placebo or no active drug intake, when administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline (BL) in trough forced expiratory volume in one second (FEV1) on Day 85
Timeframe: Baseline and Day 85
Secondary outcomes:
Change from Baseline in weighted mean (WM) 0-6 hour FEV1 obtained post-dose at Days 1, 28 (Week 4) and 84 (Week 12)
Timeframe: Baseline and Days 1, 28 and 84
Change from Baseline in serial FEV1 over 24 hours post-dose at Days 1 and 84 (Week 12)
Timeframe: Baseline, Day 1 and Day 84
Interventions:
Drug: GSK573719
Other: Placebo
Enrollment:
206
Observational study model:
Not applicable
Primary completion date:
2012-13-02
Time perspective:
Not applicable
Clinical publications:
Trivedi R, Richard N, Mehta R, Church A . Umeclidinium monotherapy in patients with COPD: a randomised, placebo-controlled study. Eur Respir J. 2014;43(1):72-81.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
Not applicable
Study date(s)
July 2011 to February 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Diagnosis of COPD
- 10 pack-year or greater history of cigarette smoking
- Women who are pregnant, lactating, or planning to become pregnant
- Respiratory disorders other than COPD, including a current diagnosis of asthma
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of COPD -10 pack-year or greater history of cigarette smoking -Post-bronchodilator FEV1/FVC of <0.7 -Predicted FEV1 of 70% of normal or less -Modified Medical Research Council (mMRC) dyspnea score of 2 or greater
Exclusion criteria:
- Women who are pregnant, lactating, or planning to become pregnant -Respiratory disorders other than COPD, including a current diagnosis of asthma -Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled -Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device -Hospitalization for COPD or pneumonia within 12 weeks prior to screening -Lung volume reduction surgery within 12 weeks prior to screening -Abnormal and clinically significant ECG findings at screening -Clinically significant laboratory findings at screening -Use of systemic corticosteroids, antibiotics for respiratory tract infections, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit -Use of long-term oxygen therapy (12 hours or greater per day) -Regular use of nebulized treatment with short-acting bronchodilators -Participation in the acute phase of a pulmonary rehabilitation program -A know or suspected history of alcohol or drug abuse -Affiliation with the investigational site -Previous use of GSK573719 or the combination of GSK573719/GW642444
Trial location(s)
Location
GSK Investigational Site
Teuchern, Sachsen-Anhalt, Germany, 06682
Status
Study Complete
Location
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42651
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
Status
Study Complete
Location
GSK Investigational Site
Weyhe-Leeste, Niedersachsen, Germany, 28844
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-13-02
Actual study completion date
2012-13-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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