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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Seretide; Drug: Flixotide; Drug: Flutiform

• Registration Number: NCT01511367
• Lead Sponsor: Mundipharma Research Limited

Brief 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.

Study Timeline

• Study First Submitted: 2011-12-07
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-18
• Study Start: 2012-03
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seretide	Seretide	-
Flixotide	Flixotide	-
Flutiform	Flutiform	-

Primary Outcome Measures

Name	Time	Method
To show superiority in the efficacy of Flutiform pMDI 50/5μg (2 puffs bid) versus fluticasone pMDI 50 μg (2 puffs bid).	12 weeks	Change from pre-dose Forced Expiratory Volume in one second (FEV1) in litres at baseline to 2 hours post-dose FEV1 at the end of the 12 week treatment period.

Secondary Outcome Measures

Name	Time	Method
Show non-inferiority in the efficacy of Flutiform to Seretide	12 weeks	Change from pre-dose FEV1 at baseline to 2 hours post-dose FEV1 at Day 1 and FEV1 AUC0-4 at Day 1 and Week 12 (Flutiform vs Seretide)

Trial Locations

Locations (4)

Illés és Ádám Egészségügyi Szolgáltató Bt.; 🇭🇺 Kiskunhalas, Hungary

Alergologie Skopkova s.r.o; 🇨🇿 Ostrava-Marianske Hory, Czechia

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp.z.o.o.; 🇵🇱 Tarnow, Poland

Spitalul Judetean de Urgenta Deva; 🇷🇴 Deva, Hunedoara, Romania