CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,128 enrolled
Drug / intervention
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) +2 moredrug
Likely dose
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) 100 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/NCT02245672
NCT02245672Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Double Dummy, Parallel Group Study to Determine the Local Equivalence of Multiple Doses of MGR001 to Advair Diskus Administered Via Oral Inhalation in Adult Asthma Patients

Mylan Pharma UK Ltd.·interventional·Posted Sep 19, 2014·Updated Feb 24, 2022

In Brief

A Phase 3 clinical trial evaluating MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate), Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate), and 1 other intervention for Asthma. Completed, enrolled 1,128 participants across 101 sites.

Detailed Summary

The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 19, 2014
Enrollment StartOct 1, 2014
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.8 years ago

Interventions

MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)drug

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device

Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)drug

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device

Placebodrug

Placebo administered via the CRC749 and Diskus devices