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Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma

NCT00556673 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2013-04-22

Study results available
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Summary

This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.

Conditions

Interventions

DRUG

indacaterol maleate/mometasone furoate

Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.

DRUG

placebo to indacaterol maleate/mometasone furoate

Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

DRUG

fluticasone proprionate / salmeterol xinafoate

Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis investigator site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • France
  • Germany

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 NCT00556673 on ClinicalTrials.gov