Efficacy and safety.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
24-hour weighted-mean FEV1 on Treatment Day 84.
Secondary outcome
Trough FEV1 on day 85, adverse events.
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 devoped
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 Seretide (fluticasone propionate/salmeterol) twice daily.
Study objective
Efficacy and safety.
Study design
Multicenter randomized double blind phase III parallel group study. Run-in
period of 1-2 weeks.
Randomisation (1:1) to treatment with:
* umeclidinium/vilanterol (62,5/25 mcg) once daily
* Seretide (fluticasone propionate/salmeterol 500/50 mcg) twice daily
administration as inhaled dry powder formulation.
Treatment duration 12 weeks. Total study duration appox. 15 weeks.
Approx 710 patients randomized.
Intervention
Treatment with umeclidinium/vilanterol or Seretide.
Study burden and risks
Risk: Adverse effects of study medication.
Burden: 6 visits in 15 weeks plus 1 telephone contact. Duration 1-24 h ( 2 long
measurement days of approx. 6 and 24 h), final visit may be performed by
telephone.
Pulmonary function tests: 1x incl. reversibility. During every visit, thereof 2
visits with serial measurements during 6 and 24 h resp. During 24 h measurement
overnight stay in hotel near hospital.
Physical examination 2x.
Optional pharmacogenetic research (saliva).
Pregnancy test (if relevant) 3x, ECG 1x. Questionnaires 4x.
Daily completion of diary.
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 23 for details).
* (Ex) smokers, at least 10 pack years.
* Pre and post salbutamol FEV1/FVC ratio <70%.
* Post salbutamol FEV1 *30% 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.
* Bronchial asthma.
* Documented COPD exacerbation in the past 12 months.
* Hospitalization for COPD or pneumonia in the past 12 weeks.
* Significant ECG abnormalities (see protocol page 24 for details).
* Treatment with specified (mainly COPD) therapies within a specified time frame (see protocol page 24-25 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 | EUCTR2012-000524-18-NL |
| CCMO | NL43355.060.13 |
| Other | www.gsk-clinicalstudyregister.com; registratienummer n.n.b. |