An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent and Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
- Registration Number
- NCT00563056
- Lead Sponsor
- Mundipharma Research Limited
- Brief Summary
Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.
- Detailed Description
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive Flutiform® or Flixotiole® and Foradil® as individual componements. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 227
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flutiform Flutiform 2 puffs 50/5 or 125/5 mcg Flixotide plus Foradil Flixotide plus Foradil Flixotide 2 puffs 50 or 125 mcg; Foradil 1 puff 12 mcg
- Primary Outcome Measures
Name Time Method Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values. 12 weeks
- Secondary Outcome Measures
Name Time Method Discontinuation, PEFR, rescue medication use, asthma symptom scores, sleep disturbance, AQLQ, exacerbations, patient acceptance 12 weeks
Trial Locations
- Locations (2)
Research site
🇳🇱Nieuwegein, Netherlands
Research Site
🇬🇧Chesterfield, United Kingdom