Hyperreactive AirwayNCT01963585
Evaluating the Capacity of High-sensitivity Serum CRP Levels to Predict Bronchial Hyper Responsiveness in School Age Children
An observational study of Hyperreactive Airway, run by Rambam Health Care Campus.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperreactive Airway
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: subjects (age range 6 to 18 years) referred for Methacholine Challenge Test (MCT)
Who may be able to join
- Age range 6 to 18 years
- Patient referred for Methacholine Challenge Test (MCT)
Who cannot join
- 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
About this study
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.
Read more
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.
- Conditions
- Hyperreactive Airway
- Keywords
- C reactive protein, Airway hyperreactivity, Body mass index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Negative metacholine | Healthy control | |
| Positive metacholine | Hyperreactive airway disease - study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIgh sensitive C-reactive protein
in peripheral Blood count
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
Secondary outcomes (5)
Metacholine Challenge Test
As assessed by methacholine challenge test with determination of PC20.
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
IgE
in peripheral Blood count
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
complete blood count
in peripheral Blood count
Measured: 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
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
body mass index
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperreactive AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963585
- Sponsor's protocol ID
- 0200-11
- Status last verified
- Oct 2013
- First submitted
- 13 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
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.
PubMed 25331535
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Capacity of High-sensitivity Serum CRP Levels to Predict Bronchial Hyper Responsiveness in School Age Children
- ClinicalTrials.gov ID
- NCT01963585
- Acronym / sponsor ID
- 0200-11
- Conditions
- Hyperreactive Airway
- Keywords
- C reactive protein, Airway hyperreactivity, Body mass index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative metacholine | – | –Healthy control |
| Positive metacholine | – | –Hyperreactive airway disease - study group |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- subjects (age range 6 to 18 years) referred for Methacholine Challenge Test (MCT)
Key inclusion criteria (2 listed)
- Age range 6 to 18 years
- Patient referred for Methacholine Challenge Test (MCT)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HIgh sensitive C-reactive protein
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
in peripheral Blood count
5 secondary outcomes
Metacholine Challenge Test
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
IgE
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
complete blood count
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
Fractional Exhaled NO
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
body mass index
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Derived from this study: PubMed 25331535Livnat 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperreactive Airway, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIgh sensitive C-reactive protein (time frame: participants will be followed for the duration of hospital visit, an average of 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.