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

Asthma Bronchiale Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Asthma
• Asthma Bronchiale

• NCT number: NCT00563056
• Study type: Interventional
• Source: Mundipharma Research Limited
• Status: Completed
• Phase: Phase 3
• Start date: September 2007
• Completion date: April 2008