NCT00563056

An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent and Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma

Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.

Detailed description

This is a study involving a 12 week treatment phase. During the treatment phase subjects receive Flutiform® or Flixotiole® and Foradil® as individual componements. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.

Conditions

• Asthma Bronchiale

Interventions

Type	Name	Description
DRUG	Flutiform
DRUG	Flixotide plus Foradil

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-11-26
• Last updated: 2018-10-24

Locations

6 sites across 6 countries: Germany, Hungary, Netherlands, Poland, Romania, United Kingdom