NCT00563056
Completed
Phase 3
Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
ConditionsAsthma Bronchiale
Overview
- Phase
- Phase 3
- Intervention
- Flutiform
- Conditions
- Asthma Bronchiale
- Sponsor
- Mundipharma Research Limited
- Enrollment
- 227
- Locations
- 2
- Primary Endpoint
- Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Flutiform
2 puffs 50/5 or 125/5 mcg
Intervention: Flutiform
Flixotide plus Foradil
Flixotide 2 puffs 50 or 125 mcg; Foradil 1 puff 12 mcg
Intervention: Flixotide plus Foradil
Outcomes
Primary Outcomes
Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values.
Time Frame: 12 weeks
Secondary Outcomes
- Discontinuation, PEFR, rescue medication use, asthma symptom scores, sleep disturbance, AQLQ, exacerbations, patient acceptance(12 weeks)
Study Sites (2)
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