CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 841 enrolled
Drug / intervention
Fluticasone Propionate +2 moredrug
Likely dose
Not stated in 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/NCT02980133
NCT02980133Phase 3Completed
CompareCT.gov

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years With Persistent Asthma

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Dec 2, 2016·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating Fluticasone Propionate, Fluticasone Propionate/Salmeterol, and 1 other intervention for Asthma. Completed, enrolled 841 participants across 118 sites in 5 countries.

Detailed Summary

This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGeorgia, Hungary, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2, 2016
Enrollment StartDec 28, 2016
Primary CompletionApr 7, 2019
Study CompletionApr 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.6 years ago

Interventions

Fluticasone Propionatedrug

Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.

Fluticasone Propionate/Salmeteroldrug

Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.

Placebo MDPIdrug

Matching placebo was administered via MDPI per the schedule specified in the arm.