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

NCT02649478 NA COMPLETED

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

Details

Lead sponsor	Roxane Laboratories
Phase	NA
Status	COMPLETED
Enrolment	1430
Start date	2014-08
Completion	2015-11

Conditions

• Asthma

Interventions

• Fluticasone / Salmeterol
• Placebo
• Advair Diskus 100/50

Primary outcomes

• Baseline-adjusted area under the serial FEV1-time curve from time 0 to 12 hours on the first day of the Treatment Period — 0-12 hours after dosing on Day 1
• Baseline-adjusted, pre-dose FEV1 on the last day of the Treatment Period — 30 Days

Countries

United States