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

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.

Study Overview

• Status: Completed
• Conditions: Hyperreactive Airway

• Study Type: Observational
• Enrollment (Actual): 131

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects (age range 6 to 18 years) referred for Methacholine Challenge Test (MCT)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Negative metacholine; Healthy control
Positive metacholine; Hyperreactive airway disease - study group

What is the study measuring?

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
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
complete blood count	in peripheral Blood count	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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Publications and helpful links

General Publications

• Livnat G, Yoseph RB, Nir V, Hakim F, Yigla M, Bentur L. Evaluation of high-sensitivity serum CRP levels compared to markers of airway inflammation and allergy as predictors of methacholine bronchial hyper-responsiveness in children. Lung. 2015 Feb;193(1):39-45. doi: 10.1007/s00408-014-9658-6. Epub 2014 Oct 21.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: October 13, 2013
• First Submitted That Met QC Criteria: October 13, 2013
• First Posted (ESTIMATE): October 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 13, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Body mass index; C reactive protein; Airway hyperreactivity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchial Hyperreactivity
• Other Study ID Numbers: 0200-11