Bronchial Hyperreactivity in Children With Crohn Disease

February 16, 2011 updated by: Rambam Health Care Campus

Background: Latent pulmonary involvement is described in Crohn Disease(CD). Bronchial hyperreactivity measured by the Methacholine Challenge Test (MCT) has been evaluated in two studies involving mainly adults.Our aim was to determine the frequency of bronchial hyperreactivity in pediatric patients followed and treated for Crohn disease.

Methods: Twenty-three children with Crohn disease completed a questionnaire, followed by spirometry, Methacholine Challenge Test (MCT) and determination of Fractional Exhaled NO (FENO). The control group included patients evaluated for functional cough who had negative Methacholine Challenge Test (MCT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 32000
        • Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twenty-three children with Crohn disease in the age of 11 to 22 yr

Description

Inclusion Criteria:

  • Children with Crohn disease
  • Children that can perform lung function tests (MCT)

Exclusion Criteria:

  • Upper respiratory tract infection last month
  • Fever or Pneumonia last month
  • Smoking
  • Other chronic diseases
  • Other respiratory diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Crohn's Patients
Random Crohn's Disease Patients that can perform Methacholine Challenge Test (MCT)
Other: Methacholine Challenge Test
Methacholine challenge test to evaluate airway hyperreactivity
Other: Fractional Exhaled NO (FENO)
Fractional Exhaled NO to evaluate eosinophilic inflammation
Other: Blood Test
Blood Tests (Eosinophil Count)
Other: PCDAI
Clinical Evaluation for Pediatric Crohn's Disease Activity Index (PCDAI)
Negative MCT
Patients evaluated for functional cough who had negative Methacholine Challenge Test (MCT)
Other: Methacholine Challenge Test
Methacholine challenge test to evaluate airway hyperreactivity
Other: Fractional Exhaled NO (FENO)
Fractional Exhaled NO to evaluate eosinophilic inflammation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methacholine challenge test
Time Frame: 18 months
As assessed by methacholine challenge test with determination of PC20.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional Exhaled NO
Time Frame: Day 1
Exhaled NO test
Day 1
Eosinophils count
Time Frame: Day 1
blood test
Day 1
Pediatric Crohn's Disease Activity Index (PCDAI)
Time Frame: Day 1
Clinical Evaluation
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Estimate)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Crohn's

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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