A 12-week, randomised, double-blind, placebo-controlled, parallel-group multicentre study to evaluate the anti-inflammatory activity of GW842470 4mg twice daily on pulmonary hyperinflation in patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD) - Stage II or III
- Registration Number
- EUCTR2004-000789-11-ES
- Lead Sponsor
- GlaxoSmithKline SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. Male or female adults between 40 and 80 years of age (inclusive).
Females are eligible if they are of:
a) Non childbearing potential
b) Child-bearing potential, have a negative pregnancy test at entry, and use adequate contraceptive methods
2. Moderate to severe stable COPD (Stage II or III) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
3. A cigarette smoking history of greater or equal to 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or the equivalent). Both current smokers and ex-smokers are eligible.
4. A post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) < 0.7.
5. A post-bronchodilator FEV1 greater or equal to 30% and <80% of predicted normal for height, age and sex at Screening. Patients will be assessed 30 minutes after receiving salbutamol 400mcg via MDI with a spacer.
6. Evidence of hyperinflation as assessed by (pre-bronchodilator) thoracic gas volume at functional residual capacity (TGVFRC) measured by plethysmography of >120% of predicted TGVFRC and a residual volume (RV) measured by plethysmography >120% of predicted RV at screening.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Women who are pregnant or lactating.
2. Women with a positive pregnancy test at Screening.
3. Patients with asthma as the main component of their obstructive airways disease.
4. Patients with poorly controlled COPD, defined as the occurrence of any of the following in the 6 weeks prior to Screening; acute worsening of COPD that was managed by the patient at home by self-treatment with corticosteroids or antibiotics, or that required treatment prescribed by a physician.
5. Patients who have been hospitalized for an exacerbation of COPD in the 6 weeks prior to Screening.
6. Patients with active tuberculosis, lung cancer, or clinically overt bronchiectasis or any other condition known to be associated with inflammation (sarcoidosis and arthritis)
7. Patients with clinically significant cardiovascular, neurological, renal, endocrine, or haematological abnormalities that are uncontrolled on permitted therapy.
8. Patients with clinically significant gastrointestinal or hepatic abnormalities.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method