Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: *Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition). *Spirometry values (post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] less than [= 6 months prior to Screening Visit 1 and at a stable dose for >=3 months *Documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening.
Exclusion criteria
Exclusion criteria: *Significant pulmonary disease other than COPD. *Requirement for continuous chronic treatment with oxygen at >4.0 liters / minute by nasal cannula or equivalent. *Hypoxemia with a resting SpO2 <88% while breathing ambient air (or on the participant's usual level of oxygen supplementation). *Clinically significant cardiovascular disease, acute and/or severe left heart failure, or heart failure partial ejection fraction, and/or cor pulmonale.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 *Phase 3 part: Annualized rate of moderate or severe ECOPD | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2 part: *Annualized rate of moderate or severe ECOPD *Change from baseline in pre-BD FEV1 up to Week 24 *Change from baseline in trough, pre- and post-BD FEV1 up to Week 24 *Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24 *Change from baseline in trough FEV1 responsiveness to BD up to Week 24 *Incidence and severity of TEAEs throughout Phase 2 part of the study *Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation *Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs *Change from baseline in clinical laboratory values, ECG measurements, and vital signs Phase 3 part: *Change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52 *Percentage of participants with >=4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52 *Percentage of participants with >=2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52 *Percentage of participants with >=2 points improvement from baseline in E-RS:COPD total score at Week 52 *Annualized rate of severe ECOPD *Annualized rate of exacerbations requiring emergency department visit and/or hospitalization | — |
Countries
Canada, China, India, Japan, South Korea, Taiwan, United States
Contacts
Pfizer R&D Japan G.K.