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

Completed

• Conditions: Hyperreactive Airway

• Registration Number: NCT01963585
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-09
• Status Verified: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2013-10-13
• Study First Submitted QC: 2013-10-13
• Last Update Submitted: 2013-10-13
• Study First Posted: 2013-10-16
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HIgh sensitive C-reactive protein	participants will be followed for the duration of hospital visit, an average of 3 hours	in peripheral Blood count

Secondary Outcome Measures

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