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.
Overview
- Phase
- Phase 3
- Intervention
- Flutiform 250/10 micrograms
- Conditions
- Asthma, Bronchial
- Sponsor
- Mundipharma Research Limited
- Enrollment
- 1667
- Primary Endpoint
- Comparison of FEV1 (Forced expiratory volume in the first second) values.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Flutiform 250/10 micrograms
Flutiform 250/10 micrograms (2 puffs bd)
Intervention: Flutiform 250/10 micrograms
Flutiform 50/5 micrograms
Flutiform 50/5 micrograms (2 puffs bd)
Intervention: Flutiform 50/5 micrograms
Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms
Flixotide pMDI 250 mcg (2 puffs bd) + foradil pMDI 24 50/5 mcg (bd)
Intervention: Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms
Flixotide pMDI 250 micrograms
Flixatide pMDI 250 micrograms (2 puffs bd)
Intervention: Flixotide pMDI 250 micrograms
Outcomes
Primary Outcomes
Comparison of FEV1 (Forced expiratory volume in the first second) values.
Time Frame: 8 weeks
8 weeks on treatment
Secondary Outcomes
- Other lung function parameters, asthma symptom scores, sleep disturbance due to asthma, rescue medication use, AQLQ, safety assessments.(8 weeks)