chronic obstructive airways disease (COPD)
Conditions
Interventions
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Males and females 40 years and above. * COPD based on ATS/ERS current guidelines. * Current and former smokers with a cigarette smoking history of *10 pack years. See protocol page 27 for details. * Female participants of childbearing potential who agrees to follow the contraceptive guidance page 27-28 of the protocol.
Exclusion criteria
Exclusion criteria: * Asthma, alpha-1-antitrypsin deficiency or other relevant respiratory disorder, see protocol page 28 for details. * Unstable liver disease or unstable or life threatening cardiac disease, see protocol page 28-29 for details. * Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction, unless, in the opinion of the study physician, the benefit outweighs the risk. * Hospitalization for COPD or pneumonia within 12 weeks prior to screening. * Had received ICS or ICS/LABA for COPD in the 6 weeks prior to screening. * Had >1 moderate exacerbation in the 12 months prior to screening, or 1 severe exacerbation requiring hospitalisation in the 12 months prior screening. * Respiratory tract infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in FEV1 at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in transient dyspnea index (TDI) over 24 weeks. Respiratory daily symptoms over 24 weeks using Evaluating Respiratory Symptoms- COPD (E-RS). Change from baseline for the St. George*s Respiratory Questionnaire (SGRQ-C). Change from baseline in COPD assessment test (CAT). COPD exacerbations. Clinically important deterioration (CID, composite endpoint). Rescue medication use. Lung function parameters. Global impression disease severity. Adverse events. | — |
Countries
Argentina, Australia, Canada, France, Germany, Italy, Mexico, Netherlands, South Africa, Spain, Sweden, United States of America
Outcome results
None listed