A Randomised, Double Blind, Double Dummy, Parallel Group Study Comparing UMEC/VI (A Fixed Combination Of Umeclidinium and Vilanterol) With Tiotropium In COPD Subjects Who Continue To Have Symptoms on Tiotropium (DB2116960)
- Conditions
- COPD10038716
- Registration Number
- NL-OMON38952
- Lead Sponsor
- GlaxoSmithKline BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 45
• COPD patients >=40 years of age (see protocol page 26 for details).
• Treatment with tiotropium for at least 3 months prior to screening (see protocol page 26 for details).
• (Ex) smokers, at least 10 pack years.
• Pre and post salbutamol FEV1/FVC ratio <70%.
• Post salbutamol FEV1 >=50% and <=70% of predicted.
• A score of at least 2 on the Modified Medical Research Council Dyspnea Scale.
• Safe contraception for women of childbearing potential.
• Pregnancy, lactation.
• Bronchial asthma.
• More than 1 COPD exacerbation in the past 12 months. Exacerbation in the last 6 weeks.
• Significant ECG abnormalities (see protocol page 28 for details).
• Currently taking an inhaled corticosteroid as part of their maintenance treatment for COPD.
• Treatment with other specified (mainly COPD) therapies within a specified time frame (see protocol page 28-30 for details).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Through FEV1 on Treatment Day 85.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Adverse events, FEV1 3 h post dose on day 84, other pulmonary function test<br /><br>parameters, use of rescue medication, questionnaires.</p><br>