Asthma Clinical Trial
Official title:
A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared With Advair Diskus® 100/50 in Subjects With Asthma
A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma
The primary objective of this study is to evaluate the clinical bioequivalence of generic
fluticasone propionate 100 μg and salmeterol xinafoate 50 μg 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 μg and
salmeterol xinafoate 50 μg inhalation powder to placebo.
- To demonstrate statistical superiority of Advair 100/50 to placebo.
- To investigate the safety and tolerability of fluticasone propionate 100 μg and
salmeterol xinafoate 50 μg inhalation powder compared with Advair 100/50 in the target
population
;
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