NCT02649478

Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,430 (actual)
• Sponsor: Roxane Laboratories · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone / Salmeterol	Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Vectura LOMI inhaler device
DRUG	Placebo
DRUG	Advair Diskus 100/50	Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device)

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2016-01-07
• Last updated: 2018-01-23

Locations

100 sites across 1 country: United States