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Clinical Trial Summary

The purpose of the trial is 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 will assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.


Clinical Trial Description

The primary objective of this study is 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 is 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02892344
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email trialandresults.registries@novartis.com
Status Recruiting
Phase Phase 3
Start date May 17, 2010
Completion date August 31, 2018