Hyperreactive Airway Clinical Trial
Official title:
Evaluating the Capacity of High-sensitivity Serum CRP Levels to Predict Bronchial Hyper Responsiveness in School Age Children
| Verified date | October 2013 |
| Source | Rambam Health Care Campus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 131 |
| Est. completion date | October 2013 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Years to 18 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HIgh sensitive C-reactive protein | in peripheral Blood count | participants will be followed for the duration of hospital visit, an average of 3 hours | No |
| Secondary | 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 | Yes |
| Secondary | IgE | in peripheral Blood count | participants will be followed for the duration of hospital visit, an average of 3 hours | No |
| Secondary | complete blood count | in peripheral Blood count | participants will be followed for the duration of hospital visit, an average of 3 hours | No |
| Secondary | 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 | No |
| Secondary | body mass index | participants will be followed for the duration of hospital visit, an average of 3 hours | No |