NCT01099722

Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort® Turbohaler® 200/6 µg (2 Puffs Bid) in Adolescent and Adult Subjects With Moderate to Severe Persistent, Reversible Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

A comparator study to assess safety and efficacy of Flutiform® compared with symbicort turbohaler in asthma patients with moderate to severe persistent, reversible asthma.

Detailed description

This is a study involving a 2-4 week run-in phase followed by a 12 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 two treatment groups and will receive either FlutiForm® and placebo inhaler for symbicort® turbohaler® or symbicort® turbohaler® and placebo inhaler for Flutiform ® . 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

Interventions

Type	Name	Description
DRUG	Flutiform	inhaler 2 puffs bd daily
DRUG	Symbicort Turbohaler	2 puffs bd daily

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-11-01
• Completion: 2011-07-01
• First posted: 2010-04-07
• Last updated: 2018-10-24

Locations

5 sites across 5 countries: Bulgaria, Hungary, India, Poland, Romania