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
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