chronic obstructive airways disease (COPD)
Conditions
Interventions
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * 40 to 80years of age inclusive. * COPD based on ATS/ERS current guidelines. * Symptoms including chronic cough, mucus hypersecretion, and dyspnea on most days for at least the previous 3 months. * Documented history of COPD exacerbation(s) in the previous year. See protocol page 28 for details. * Current and former smokers with a cigarette smoking history of *10 pack years. See protocol page 28 for details. * Female participant of childbearing potential and male participant who agrees to follow the contraceptive guidance in appendix5 of the protocol during the treatment period and for at least 60 hours after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: * Diagnosis of other clinically relevant lung diseases (other than COPD). * Alpha-1-antitrypsin deficiency. * Less than 14 days have elapsed from the completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation. * Peripheral blood neutrophil count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in respiratory symptoms measured by the E-RS:COPD daily diary. Adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of annual COPD exacerbations. Time to first exacerbation. Change from baseline for the St. George*s Respiratory Questionnaire total score and other SGRQ parameters. Lung function (FEV1, FEV1 % predicted, FVC, FEV1/FVC ratio). Rescue medication use. PK parameters. | — |
Countries
Australia, Canada, Germany, Korea (the Republic of), Netherlands, Poland, Romania, Spain, United States of America
Outcome results
None listed