Clinical Endpoint Bioequivalence Study of Fluticasone Propionate & Salmeterol Xinafoate (100 g/50 g)

  • STATUS
    Not Recruiting
  • participants needed
    2333
  • sponsor
    West-Ward Pharmaceutical
Updated on 23 January 2021
corticosteroids
pulmonary function test
fluticasone
persistent asthma
salmeterol
dry powder inhaler
advair
theophylline

Summary

A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 g and Salmeterol Xinafoate 50 g Inhalation Powder Compared with Advair Diskus 100/50 in Subjects with Asthma

Description

The primary objective of this study is to evaluate the clinical bioequivalence of generic fluticasone propionate 100 g and salmeterol xinafoate 50 g inhalation powder (test) to Advair Diskus ("Advair") 100/50 (reference) for the treatment of asthma.

The secondary objectives of the study are:

  • To demonstrate statistical superiority of generic fluticasone propionate 100 g and salmeterol xinafoate 50 g inhalation powder to placebo.
  • To demonstrate statistical superiority of Advair 100/50 to placebo.
  • To investigate the safety and tolerability of fluticasone propionate 100 g and salmeterol xinafoate 50 g inhalation powder compared with Advair 100/50 in the target population

Details
Condition Asthma
Treatment Placebo, Fluticasone propionate/salmeterol, Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder
Clinical Study IdentifierNCT03535870
SponsorWest-Ward Pharmaceutical
Last Modified on23 January 2021

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