Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years

Study Overview
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Brief Summary
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Rational: The possible contribution of methacholine challenge test via spirometry to the clinical diagnosis of young children with various respiratory symptoms, the most appropriate spirometry index, and the proper cutoff point concentration that will define airway sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry in a large group of children aged 3-6years with various respiratory symptoms.

Detailed Description
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We aimed to gather information concerning methacholine challenge test performed in children previously diagnosed with asthma (asthmatics) and 48 had prolonged cough (coughers) from the pediatric clinic at Meyer Children's Hospital. Tests were performed by inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine). Spirometry was determined at baseline and after each inhalation in duplicate sets. End of test was defined by a fall of 20%FEV1 baseline (PC20-FEV1). PC20-FEV1<4.0mg/ml was considered positive). Results from the challenge were related to data from questionnaires concerning respiratory symptoms were analyzed at the end of the studies.

Official Title
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The Effect of Singular (Montelukast) 4mg on Hypersensitivity of the Airways in Children 3-5 Years Old. + Extended Study Hyprsensitivity of the Airways in Asthmatic Children Age 3-6years

Conditions
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Asthma, Recurrent Cough

Intervention / Treatment
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* Drug: Methachoine
* Device: spirometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 3- to 6-years respiratory diseases who were highly indicative of asthma diagnosis according to GINA guidelines [9] cough duration of more than 4 weeks normal chest auscultation and baseline FEV1>75% predicted for healthy preschool children, on the day of testing. Exclusion Criteria: presence of other chronic respiratory conditions emergency room visit or the presence of respiratory infection within the last month oral or inhaled steroids or other anti-inflammatory medication taken in the last two weeks bronchodilator taken within 24-hours prior to the test.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methachoine|inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine)|
|Device: spirometry|spirometry|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1) |  | after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methacholine challenge; Spirometry, Early childhood