NCT00557440

Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma

A Multi-center, Randomized, Double-blind, Double Dummy, Placebo and Active Controlled Crossover Study, to Investigate the 24 Hour FEV1 Profile of a Single Dose of QMF TWISTHALER Device in Adult Patients With Persistent Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	fluticasone propionate/salmeterol	Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI.
DRUG	indacaterol maleate / mometasone furoate	Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device.
DRUG	placebo to indacaterol/mometasone	Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device.
DRUG	placebo to fluticasone propionate/salmeterol	Placebo to fluticasone propionate / salmeterol delivered via MDDPI.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-11-14
• Last updated: 2013-03-21
• Results posted: 2013-03-21

Locations

6 sites across 2 countries: Belgium, Germany