NCT01511367

Comparison of Flutiform, Fluticasone and Seretide in Treatment of Moderate to Severe Asthma in Paediatric Patients

A Double-blind, Double Dummy, Randomised, Parallel Group, Multicentre Study to Compare the Efficacy and Safety of Flutiform pMDI With Fluticasone pMDI and With Seretide pMDI in Paediatric Subjects Aged 5 to Less Than 12 Years With Moderate to Severe Persistent Reversible Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 498 (estimated)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This is a comparator study to assess safety and efficacy of Flutiform compared with Fluticasone pMDI and Seretide pMDI in paediatric 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, all subjects receive Flixotide. In the treatment phase subjects will be randomised to one of the 3 treatment groups and will receive active Flutiform and placebo Flixotide or Active Seretide and placebo Flixotide or active Flixotide and either placebo seretide or placebo 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, urinary cortisol and vital signs.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Flutiform	50/5ug (fluticasone/formoterol) 2 puffs twice daily
DRUG	Seretide	50/25 ug (fluticasone/salmeterol) 2 puffs twice daily
DRUG	Flixotide	50ug 2 puffs twice daily

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2012-01-18
• Last updated: 2018-10-24

Locations

8 sites across 8 countries: Bulgaria, Czechia, Hungary, India, Poland, Romania, Russia, Ukraine