The primary objective of this study is to evaluate efficacy and safety. Secondary objectives: PK, PK-PD.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from baseline in trough FEV1 on Day 169.
Secondary outcome
PK, PK-PD.
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.
GSK573719 is a longacting muscarinic antagonist which is devoped as a dry
powder for inhalation in combination with the longacting beta2-agonist GW642444
as a combination product (GSK573719/GW642444) for once daily inhalation
therapy.
This study is one of two pivotal phase III studies. Efficacy and safety of the
combination product iwill be compared to those of each of the individual
components and placebo.
Study objective
The primary objective of this study is to evaluate efficacy and safety.
Secondary objectives: PK, PK-PD.
Study design
Multicenter randomized double blind phase III parallel group study en active
and placebo control. Run-in period of 1-2 weeks.
Randomisation ((3:3:3:2) to treatment with:
1. GSK573719/GW642444 125/25 mcg OD
2. GSK573719 125mcg OD
3. GW642444 25 mcg OD
4. Placebo.
Administration as inhaled dry powder formulation.
Treatmnent duration 24 weeks. Total study duration appox. 27 weeks.
Approx 1460 patients, 100 in NL.
Intervention
Treatment with GSK573719/GW642444, GSK573719, GW642444 or placebo.
Study burden and risks
Risk: Adverse effects of study medication.
Burden: 9 visits in 27 weeks. Duration 1,5-8h ( 4 long measurement days of
approx. 8 h). 1 phone call.
Pulmonary function tests: 1x incl. reversibility. During 8 visits serial
measurements (4 visits: 2 tests in 1 h, 4 visits: 7 tests in approx. 7 h).
Blood tests (safety and/or PK) during 5 visits, 42 ml in total , pregnancy test
(if relevant) 4x, ECGs during 4 vistis (thereof on 3 occasions 3 recordings).
Questionnaires 5x.
Daily completion of diary.
Optional: farmacogenetic research (10 ml blood).
Chest X-ray only if not performed in the past 6 months.
Huis ter Heideweg 62
3705 LZ Zeist
NL
Huis ter Heideweg 62
3705 LZ Zeist
NL
Listed location countries
Age
Inclusion criteria
• COPD patients >=40 years of age.
• (Ex) smokers, at least 10 pack years.
• Post salbutamol FEV1/FVC ratio <70%.
• Post salbutamol FEV1 <=70% of predicted.
• A score of >=2 on the Modified Medical Research Council Dyspnea Scale at Visit 1.
• Safe contraception for women of childbearing potential.
Exclusion criteria
• Pregnancy.
• Bronchial asthma.
• Oral steroids in the past 6 weeks.
• Hospitalization for COPD or pneumonia in the past 12 weeks.
• Significant ECG abnormalities (see protocol for details).
• Treatment with specified (mainly COPD) therapies within a specified time frame (see protocol for details).
• Previous use of GSK573719, GW642444, the GSK573719/GW642444 combination or the Fluticasone Furoate/GW642444 combination.
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 |
|---|---|
| Other | clinicaltrials.gov; registratienummer n.n.b. |
| EudraCT | EUCTR2010-023348-33-NL |
| CCMO | NL35607.060.11 |