NL-OMON38952WithdrawnPhase 3
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) - DB2116960
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- GlaxoSmithKline BV
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Investigators
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