Clinical Trials Directory

Trials / Completed

CompletedNCT00556673

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

An Exploratory, Multi-centre, Double-blind, Placebocontrolled Crossover Study, to Investigate the Bronchodilatory Efficacy of a Single Dose of Indacaterol in Fixed Combination With Mometasone Furoate Delivered Via a MDDPI (Twisthaler®) in Adult Patients With Persistent Asthma Using Open Label Seretide® Accuhaler® (50/250 Mcg b.i.d.) as an Active Control

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
31 (actual)
Sponsor
Novartis · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DRUGindacaterol maleate/mometasone furoateIndacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.
DRUGplacebo to indacaterol maleate/mometasone furoatePlacebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
DRUGfluticasone proprionate / salmeterol xinafoateFluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.

Timeline

Start date
2007-10-01
Primary completion
2008-04-01
Completion
2008-04-01
First posted
2007-11-12
Last updated
2013-04-22
Results posted
2013-04-22

Locations

2 sites across 2 countries: France, Germany

Source: ClinicalTrials.gov record NCT00556673. Inclusion in this directory is not an endorsement.