At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 882 enrolled

Drug / intervention

FS MDPI +3 moredrug

Likely dose

FS MDPI 12.5 mcgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02141854

NCT02141854Phase 3Completed

Compare CT.gov

A 12-Week, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone/Salmeterol Multidose Dry Powder Inhaler in Adolescent and Adult Patients With Persistent Asthma Symptomatic Despite Inhaled Corticosteroid Therapy

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted May 20, 2014·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating FS MDPI, Fp MDPI, and 2 other interventions for Asthma. Completed, enrolled 882 participants across 154 sites in 9 countries.

Detailed Summary

The primary objective of this study was to evaluate the efficacy of fluticasone propionate (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS) MDPI when administered over 12 weeks in patients 12 years of age and older with persistent asthma.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAsthma

CountriesCanada, Czechia, Hungary, Poland, Russia, South Africa, Thailand, Ukraine, United States

Collaborators--

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

First PostedMay 2014

Enrollment StartJun 2014

Primary CompletionSep 2015

TodayJul 2026

First PostedMay 20, 2014

Enrollment StartJun 1, 2014

Primary CompletionSep 1, 2015

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 12.1 years ago

Interventions

FS MDPIdrug

FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to either fluticasone propionate/salmeterol MDPI 200/12.5 mcg or fluticasone propionate/salmeterol MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg. Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Fp MDPIdrug

Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to either 200 mcg or 100 mcg of Fp one inhalation twice a day for a total daily dose of 400 mcg or 200 mcg. Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Placebo MDPIdrug

The placebo multidose dry powder inhaler (MDPI) was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart). Patients were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Albuterol/salmeterol HFA MDIdrug

Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.