Evaluating the Capacity of High-sensitivity Serum CRP Levels to Predict Bronchial Hyper Responsiveness in School Age Children

Study Overview
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Brief Summary
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Background: Bronchial hyper responsiveness (BHR) assessed by methacholine challenge test (MCT) may aid in the diagnosis of asthma, while negative MCT can help to exclude the diagnosis. Laboratory measures that predict the results of MCT are expected to reduce the number of procedures. The possible capacity of High sensitive C-reactive protein (hs-CRP), a marker of systemic inflammation, to predict negative or positive MCT in children has not been evaluated. Aim: to evaluate the capacity of hs-CRP to predict positive or negative MCT in school aged children and to compare it with markers of airway inflammation: Fractional exhaled Nitric Oxide (FeNO) and markers of allergic sensitization (IgE and peripheral blood eosinophils). Design: Prospective study evaluating these parameters in patients with positive and negative MCT. Participant selection: The study population included subjects (age range 6 to 18 years) referred for Methacholine Challenge Test (MCT) Sample size: 130 participants in the two groups. Intervention: Each subject will undergo evaluation including a respiratory questionnaire, methacholine challenge test with determination of PC20(the provocative concentration that reduced FEV1 by 20% from baseline), exhaled nitric oxide (eNO). Venous blood will be analyzed for complete blood count + eosinophils, IGE levels, hs-CRP. All measurements will be evaluated in a single 3 hour visit, with no follow up study visits. Primary end point: hs-CRP levels as add on tool to predict negative or positive MCT in children Secondary outcome parameters: All other parameters are the secondary end points.

Official Title
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Evaluating the Capacity of High-sensitivity Serum CRP Levels to Predict Bronchial Hyper Responsiveness in School Age Children

Conditions
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Hyperreactive Airway

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 6 to 18 years Patient referred for Methacholine Challenge Test (MCT) Exclusion Criteria: Base line FEV1(forced expiratory volume in the first second) < 65% The presence of other systemic or lung disease Anti-inflammatory drugs Upper respiratory tract infection in the last month

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Negative metacholine<br>Healthy control | |
| Positive metacholine<br>Hyperreactive airway disease - study group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIgh sensitive C-reactive protein | in peripheral Blood count | participants will be followed for the duration of hospital visit, an average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metacholine Challenge Test | As assessed by methacholine challenge test with determination of PC20. | participants will be followed for the duration of hospital visit, an average of 3 hours | 
| IgE | in peripheral Blood count | participants will be followed for the duration of hospital visit, an average of 3 hours | 
| complete blood count | in peripheral Blood count | participants will be followed for the duration of hospital visit, an average of 3 hours | 
| Fractional Exhaled NO | determination of exhaled NO in Exhaled breath | participants will be followed for the duration of hospital visit, an average of 3 hours | 
| body mass index |  | participants will be followed for the duration of hospital visit, an average of 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C reactive protein, Airway hyperreactivity, Body mass index