ADVAIRTM DISKUS(R) (Fluticasone propionate/salmeterol inhalation powder)

1/17/02


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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

Author: CDER USER