Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: montelukast (5mg QD)
* Drug: Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of asthma for at least 6 months (per American Thoracic Society [ATS] definition). Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal. More than or 12% FEV1 reversibility following inhalation of salbutamol. Must also be symptomatic on short-acting beta-agonists. Must not have used inhaled corticosteroids over the previous month or LTRAs (Leukotriene antagonists)over the previous 2 weeks. Exclusion criteria: Hospital admission for asthma within 3 months prior to Visit 1. Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1. Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: montelukast (5mg QD)|nan|
|Drug: Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Asthma, pediatric asthmatic, asthma control