Asthma Clinical Trial
— MCH-preschoolOfficial title:
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
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.
Status | Terminated |
Enrollment | 84 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 6 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1) | after intervention |
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