NCT02496715

Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics

Randomized, Parallel, Placebo-controlled, Multiple Dose, Multicenter Study to Compare the Efficacy of Fluticasone/Salmeterol (Test) to Advair® Diskus (GSK) in Adult Asthma Patients

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a pivotal trial that will examine therapeutic equivalence (BE) of a new generic fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients with chronic but stable asthma as defined in the National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP 3) guidelines

Detailed description

This pivotal trial will examine therapeutic equivalence of a new generic fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients with chronic but stable asthma as defined in National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP 3) guidelines \[2\]. To ensure adequate study sensitivity the test and reference products should both be statistically superior to placebo (p\<0.05) with regard to the BE study primary endpoints. A secondary study objective is the safety and tolerability of the test compound.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone propionate 100 mcg / salmeterol 50 mcg	Brand inhaler containing pMDI containing fluticasone and salmeterol
DRUG	Generic fluticasone propionate 100 mcg / salmeterol 50 mcg	Generic inhaler containing pMDI containing fluticasone and salmeterol
DRUG	Placebo	Placebo inhaler

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2015-07-14
• Last updated: 2019-07-05