NCT02892344

Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 802 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. The key secondary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment.

Conditions

• Mild Asthma

Interventions

Type	Name	Description
DRUG	QMF149 150/80 μg	QMF149 150/80 μg o.d via Concept1
DRUG	MF 200 μg	MF 200 μg o.d. via Twisthaler®

Timeline

• Start date: 2017-01-16
• Primary completion: 2018-11-05
• Completion: 2018-11-30
• First posted: 2016-09-08
• Last updated: 2026-01-13
• Results posted: 2019-09-12

Locations

123 sites across 22 countries: Bulgaria, Chile, Colombia, Estonia, Germany, Hungary, India, Italy, Japan, Latvia, Lithuania, Malaysia, Peru, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Sweden, Thailand, Vietnam