A 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)
- Conditions
- 10006436chronic obstructive airways disease (COPD)
- Registration Number
- NL-OMON45687
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
* Males and females 40 years and above.
* COPD based on ATS/ERS current guidelines.
* Current and former smokers with a cigarette smoking history of *10 pack years. See protocol page 27 for details.
* Female participants of childbearing potential who agrees to follow the contraceptive guidance page 27-28 of the protocol.
* Asthma, alpha-1-antitrypsin deficiency or other relevant respiratory disorder, see protocol page 28 for details.
* Unstable liver disease or unstable or life threatening cardiac disease, see protocol page 28-29 for details.
* Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction, unless, in the opinion of the study physician, the benefit outweighs the risk.
* Hospitalization for COPD or pneumonia within 12 weeks prior to screening.
* Had received ICS or ICS/LABA for COPD in the 6 weeks prior to screening.
* Had >1 moderate exacerbation in the 12 months prior to screening, or 1 severe exacerbation requiring hospitalisation in the 12 months prior screening.
* Respiratory tract infection <7 days prior to screening.
* Use of the medications mentioned on page 30 of the protocol according to the defined time intervals prior to screening.
* Unable to read and/or not able to complete questionnaires on the electronic diary.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline in FEV1 at week 24.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change in transient dyspnea index (TDI) over 24 weeks. Respiratory daily<br /><br>symptoms over 24 weeks using Evaluating Respiratory Symptoms- COPD (E-RS).<br /><br>Change from baseline for the St. George*s Respiratory Questionnaire (SGRQ-C).<br /><br>Change from baseline in COPD assessment test (CAT). COPD exacerbations.<br /><br>Clinically important deterioration (CID, composite endpoint). Rescue medication<br /><br>use. Lung function parameters. Global impression disease severity. Adverse<br /><br>events.</p><br>