Randomised, Double-blind, Double-dummy, Parallel-group, Comparative Study of Salmeterol/FP 50/100mcg bd Inhalation Powder Via Diskus With Oral Montelukast (5mg QD) Chewable Tablets in Children 6-14 Years
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 526
- Locations
- 1
- Primary Endpoint
- Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function, asthma control, Health Outcomes including the child's quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.
Detailed Description
Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) via DISKUS† with Oral montelukast (5mg QD) Chewable Tablets in Children 6-14 years of Age with Persistent Asthma
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
Secondary Outcomes
- Changes from baseline to endpoint of:morning pre-dose FEV1 (Forced expiratory volume) symptom free 24 hour-periods rescue medication-free 24 hour-periods mean evening PEFR