Table of Contents
ADVAIRTM DISKUS(R) (Fluticasone propionate/salmeterol inhalation powder)
CLINICAL ISSUES
COMBINATION DRUG PRODUCT
DEVELOPMENT PROGRAM
OBJECTIVES
FIXED COMBINATION DRUGS POLICY
ENTRY CRITERIA
PATIENT POPULATION ENROLLED
PATIENT POPULATION ENROLLED
Percentage of Discontinuations
PRIMARY EFFICACY ENDPOINTS
EFFICACY: Pre-dose FEV1
EFFICACY: 2-hr Post-Dose FEV1
EFFICACY: ADVAIR vs. Placebo (Reversible and Non-reversible populations) Pre-Dose FEV1
EFFICACY: ADVAIR vs. Placebo (Reversible and Non-reversible populations) 2- hour post- dose FEV1
PATIENT-REPORTED OUTCOMES
Chronic Respiratory Disease Questionnaire Overall Score: Treatment Difference in Change From Baseline At Endpoint
CRDQ: Dyspnea Domain Treatment Difference in Change from Baseline at Endpoint
COPD EXACERBATIONS
Percentage of Subjects with COPD Exacerbations
Percentage of Subjects with Moderate/Severe Exacerbations
Percentage of Withdrawals Due to COPD Exacerbations
Chronic Bronchitis Symptoms Questionnaire [CBSQ]
CBSQ GAS: Treatment Difference in Change from Baseline at Endpoint
Transitional Dyspnea Index (TDI): Treatment Difference at Endpoint
SAFETY
ADVERSE EVENTS
ADVERSE EVENTS
ADVERSE EVENTS
OTHER ADVERSE EVENTS
SAFETY: Evaluation of HPA Axis Effects
SUMMARY - EFFICACY
SUMMARY - EFFICACY
SUMMARY - SAFETY
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