Agency Concerns for Discussion by PADAC: EFFICACY
Patient population
- Representative of COPD population? Reversibility
- Supportive of broad indication of “…long-term twice-daily maintenance treatment of COPD (including chronic bronchitis and emphysema)”?
Primary Endpoint: Change from baseline in FEV1
- Clinical relevance with regard to meaningful benefit to the patients?
- Adequately supported by secondary endpoints?
- Not just spirometry
- COPD exacerbation
- HRQL