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

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Completed
CT.gov ID
NCT01963585
Collaborator
(none)
131
Enrollment
27
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    131 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluating the Capacity of High-sensitivity Serum CRP Levels to Predict Bronchial Hyper Responsiveness in School Age Children
    Study Start Date :
    Jul 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Oct 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Negative metacholine

    Healthy control
    Positive metacholine

    Hyperreactive airway disease - study group

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. IgE [participants will be followed for the duration of hospital visit, an average of 3 hours]

      in peripheral Blood count

    3. complete blood count [participants will be followed for the duration of hospital visit, an average of 3 hours]

      in peripheral Blood count

    4. 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

    5. body mass index [participants will be followed for the duration of hospital visit, an average of 3 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rambam Health Care Campus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rambam Health Care Campus
    ClinicalTrials.gov Identifier:
    NCT01963585
    Other Study ID Numbers:
    • 0200-11
    First Posted:
    Oct 16, 2013
    Last Update Posted:
    Oct 16, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Rambam Health Care Campus
    C reactive protein
    Airway hyperreactivity
    Body mass index
    Additional relevant MeSH terms:
    Bronchial Hyperreactivity

    Study Results

    No Results Posted as of Oct 16, 2013