Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications

Study Overview
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Brief Summary
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This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).

Official Title
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Comparison of Stepwise Treatment of Asthmatic Children With Salmeterol/Fluticasone Propionate Combination Product (Seretide®) and/or Fluticasone Propionate (Flixotide®) Based on PD20 Methacholine and Symptoms or Based on Symptoms Only (Children Asthma Therapy Optimal)

Conditions
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Asthma

Intervention / Treatment
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* Drug: Salmeterol/Fluticasone propionate combination product
* Drug: Fluticasone propionate


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Children with a documented history of asthma. Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start. Must be able to perform reproducible lung function tests. Must have a positive RAST or skin prick test. During the treatment period, the patient has to be hyperreactive (defined as PD20 methacholine < 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period. Exclusion criteria: History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1. Admitted to hospital due to a respiratory disease 4 weeks prior to visit 1. Received oral corticosteroids within 4 weeks prior to visit 1. Existence of any disorder that affects growth. Clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting B2-agonists.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 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: Salmeterol/Fluticasone propionate combination product|nan|
|Drug: Fluticasone propionate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma symptom free days during the last 12 weeks of the treatment period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Asthma, bronchial hyperresponsiveness, symptoms