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

Phase 3

Completed

• Conditions: Asthma, Bronchial
• Interventions: Drug: Flutiform 250/10 micrograms; Drug: Flutiform 50/5 micrograms; Drug: Flixotide pMDI 250 micrograms; Drug: Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms

• Registration Number: NCT00734318
• Lead Sponsor: Mundipharma Research Limited

Brief 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.

Study Timeline

• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Study Start: 2008-09
• Primary Completion: 2009-06
• Study Completion: 2009-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1667

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flutiform 250/10 micrograms	Flutiform 250/10 micrograms	Flutiform 250/10 micrograms (2 puffs bd)
Flutiform 50/5 micrograms	Flutiform 50/5 micrograms	Flutiform 50/5 micrograms (2 puffs bd)
Flixotide pMDI 250 micrograms	Flixotide pMDI 250 micrograms	Flixatide pMDI 250 micrograms (2 puffs bd)
Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms	Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms	Flixotide pMDI 250 mcg (2 puffs bd) + foradil pMDI 24 50/5 mcg (bd)

Primary Outcome Measures

Name	Time	Method
Comparison of FEV1 (Forced expiratory volume in the first second) values.	8 weeks	8 weeks on treatment

Secondary Outcome Measures

Name	Time	Method
Other lung function parameters, asthma symptom scores, sleep disturbance due to asthma, rescue medication use, AQLQ, safety assessments.	8 weeks	8 week treatment period