FLOVENTŪ DISKUSŪ NDA 20-833, S004 GlaxoSmithKline

1/17/02


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Table of Contents

FLOVENTŪ DISKUSŪ NDA 20-833, S004 GlaxoSmithKline

Proposed Indication

Proposed Dose

Introduction

Overview

Questions for Consideration

Pivotal Studies

Efficacy Assessment

Safety Assessment

Demographics Pivotal Studies

Demographics

Reversibility Percent of Population

Mean Response to Bronchodilator % Change in FEV1

Efficacy Pivotal Studies

Mean Change From Baseline in Pre-dose FEV1, Liters Difference from Placebo

Secondary Endpoints and Patient Reported Outcomes

COPD Exacerbations % of Patients with ?1 Exacerbation

Daily Albuterol Use Mean Change From Baseline Difference from Placebo

CRDQ Change from Baseline in Overall Score Difference from Placebo

Subgroup Analysis Non-reversible Group

Subgroup Analysis, Non-reversible Group Mean Change From Baseline in Pre-dose FEV1 Difference from Placebo

Efficacy, Pivotal Studies

Safety Pivotal Studies

Notable AEs, Pivotal Studies

Notable AEs, Pivotal Studies

Adrenal Effects

FLTA3025: Serum Cortisol Percent Difference from Placebo

Cosyntropin Stimulation Testing

Safety Other Studies

FLTA1003

FLTA1003 Mean 24 Hour Urinary Cortisol Excretion

FLIT78

Notable AEs, FLIT78

Notable AEs, FLIT78

FLIT98

Bone Mineral Density

Bone Mineral Density

Conclusions

PPT Slide

Author: CDER.USER