Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD) - Stage II or III
Conditions
Interventions
Product Name: GW842470X DISKUS, 1 mg
Product Code: GW842470X
Pharmaceutical Form: Inhalation powder
Current Sponsor code: GW842470X
Other descriptive name: AWD 12-281
Concentration unit: mg milligram(
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of 12 weeks of administration of GW842470 4mg bid or placebo on pulmonary hyperinflation in terms of residual volume measured by plethysmography in patients with COPD;Secondary Objective: To evaluate the effects of 12 weeks of administration of GW842470 4mg bid or placebo on pulmonary function as assessed by spirometry and plethysmography in patients with COPD. To evaluate the systemic anti-inflammatory effect of 12 weeks of administration of GW842470 4mg bid or placebo as represented by the serum concentration of C-reactive protein, fibrinogen and inflammatory biomarkers (multiplex assay) in patients with COPD. To assess the effects of 12 weeks of administration of GW842470 4mg bid or placebo on symptoms of breathleness, cough and sputum production with questionnaires in patients with COPD To further assess the safety and tolerability of GW842470 in patients with COPD. To evaluate the plasma concentration of GW842470 over 0-6 hours at steady state. ;Primary end point(s): Change from baseline in residual volume (RV) measured by plethysmography at Week 12 | — |
Countries
Finland, Germany, Spain
Outcome results
None listed