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Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma

NCT00941798 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2283

Last updated 2012-08-31

Study results available
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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.

Conditions

Interventions

DRUG

QMF149 Twisthaler®

Once daily via multi-dose dry-powder inhaler

DRUG

Mometasone Twisthaler®

Once daily via multi-dose dry-powder inhaler

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States
  • Brazil
  • Colombia
  • Czechia
  • Hungary
  • India
  • Peru
  • Slovakia
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00941798 on ClinicalTrials.gov