Table 1.
Primary and Secondary Endpoints
| Time Point | |
|---|---|
| Primary endpoint | |
| Time-to-first event: | Through 12 months |
| Moderate or Severe COPD Exacerbations | |
| Secondary endpoints | |
| Time-to-first event | Through 12 months |
| Severe COPD exacerbations | |
| Respiratory-related hospitalizations | |
| Changes in quality of life | Through 12 months |
| SGRQ-C | |
| CAT Responders | |
| SF-36 Change | |
| Changes in dyspnea | Through 12 months |
| Transition Dyspnea Index (TDI) | |
| Changes in lung functiona | Through 12 months |
| FEV1 | |
| FVC | |
| RV | |
aChanges in lung function are measured using spirometry (FEV1 and FVC) and plethysmography (RV). Abbreviations: CAT COPD assessment test; FEV1 forced expiratory volume in 1 s; FVC forced vital capacity; IC inspiratory capacity; SF-36 short form health survey; SGRQ-C St. George’s Respiratory Questionnaire COPD version; TLC total lung capacity; TDI transition dyspnea indexes; RV residual volume