Efficacy and safety.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Through FEV1 on Treatment Day 85.
Secondary outcome
Adverse events, FEV1 3 h post dose on day 84, other pulmonary function test
parameters, use of rescue medication, questionnaires.
Background summary
COPD is a disorder characterized by airflow obstruction and reduced maximum
expiratory flow from the lungs that is not fully reversible. Previous clinical
research has indicated that combining an inhaled muscarinic antagonist with a
beta2-agonist is more effective than the individual components in managing
stable COPD to improve lung function. Therefore, the development of a new
product which combines both pharmacological approaches affords clear
advantages.
Umeclidinium (GSK573719) is a longacting muscarinic antagonist which is
developed as a dry powder for inhalation in combination with the longacting
beta2-agonist vilanterol (GW642444) as a combination product for once daily
inhalation therapy.
In this study the effects of umeclidinium/vilanterol once daily will be
compared to those of Spiriva (tiotropium) once daily.
Study objective
Efficacy and safety.
Study design
Multicenter randomized double blind phase IIIb parallel group study. Run-in
period of 4 weeks on open-label tiotropium. Only patients with a certain level
of COPD symptoms during the run-in period will be randomized.
Randomisation (1:1) to treatment with:
• umeclidinium/vilanterol (62,5/25 mcg) once daily
• tiotropium (18 mcg) once daily
administration as inhaled dry powder formulation.
Treatment duration 12 weeks. Total study duration appox.18 weeks.
Approx 670 patients.
Intervention
Treatment with umeclidinium/vilanterol or tiotropium.
Study burden and risks
Risk: Adverse effects of study medication.
Burden: 9 visits in 18 weeks. Duration 2-4 h, final visit in principle be
performed by telephone.
Pulmonary function tests: 1x incl. reversibility. Tests during 7 visits,
thereof 6 visits with serial measurements during 1 and 4 h resp.
Smoking cessation counselling
Physical examination 2x.
Optional pharmacogenetic research (saliva).
Pregnancy test (if relevant) 5x, ECG 1x. Questionnaires 5x.
Daily completion of diary (medication use, concomitant medical problems,
concomitant medication).
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-005007-41-NL |
| CCMO | NL44971.060.13 |
| Other | www.gsk-clinicalstudyregister.com; registratienummer n.n.b. |