NCT00734318

Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma

A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid) Plus Formoterol pMDI 12µg (2 Puffs Bid) Administered Concurrently in Adult Subjects With Severe Persistent, Reversible Asthma.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,667 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.

Detailed description

This is a study involving a 2 week run-in phase followed by an 8 week double blind treatment phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects will be randomised to one of the four treatment groups and will receive either high dose FlutiForm® and Foradil® plus Flixotide® placebo or low dose FlutiForm® plus Foradil® and Flixotide® placebo or Foradil® plus Flixotide® and FlutiForm® placebo or Flixotide® and FlutiForm® plus Foradil® placebo. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, ECGs and vital signs.

Conditions

• Asthma, Bronchial

Interventions

Type	Name	Description
DRUG	Flutiform 250/10 micrograms
DRUG	Flutiform 50/5 micrograms
DRUG	Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms
DRUG	Flixotide pMDI 250 micrograms

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-06-01
• Completion: 2009-10-01
• First posted: 2008-08-14
• Last updated: 2018-10-24

Locations

1 site across 1 country: Hungary