CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2,283 enrolled
Drug / intervention
QMF149 Twisthaler® +1 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/NCT00941798
NCT00941798Phase 2Completed
CompareCT.gov

A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma

Novartis Pharmaceuticals·interventional·Posted Jul 20, 2009·Updated Aug 31, 2012

In Brief

A Phase 2 clinical trial evaluating QMF149 Twisthaler® and Mometasone Twisthaler® for Asthma. Completed, enrolled 2,283 participants across 146 sites in 9 countries.

Detailed Summary

Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBrazil, Colombia, Czechia, Hungary, India, Peru, Slovakia, South Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2009
Enrollment StartJul 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.9 years ago

Interventions

QMF149 Twisthaler®drug

Once daily via multi-dose dry-powder inhaler

Mometasone Twisthaler®drug

Once daily via multi-dose dry-powder inhaler