At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 802 enrolled
Drug / intervention
QMF149 150/80 μg +1 moredrug
Likely dose
QMF149 150/80 μgfrom 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.
A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Patients With Asthma
In Brief
A Phase 3 clinical trial evaluating QMF149 150/80 μg and MF 200 μg for Mild Asthma. Completed, enrolled 802 participants across 123 sites in 22 countries.
Detailed Summary
The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d. delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Asthma
CountriesBulgaria, Chile, Colombia, Estonia, Germany, Hungary, India, Italy, Japan, Latvia, Lithuania, Malaysia, Peru, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Sweden, Thailand, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartJan 2017
Primary CompletionNov 2018
Study CompletionNov 2018
TodayJul 2026
First PostedSep 8, 2016
Enrollment StartJan 16, 2017
Primary CompletionNov 5, 2018
Study CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.8 years ago
Interventions
QMF149 150/80 μgdrug
QMF149 150/80 μg o.d via Concept1
MF 200 μgdrug
MF 200 μg o.d. via Twisthaler®