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Bronchial Hyperreactivity in Children With Crohn Disease

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01297907
First received: January 24, 2011
Last updated: February 16, 2011
Last verified: October 2007
History of Changes
  Purpose

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).


Condition Intervention
Crohn's Disease
 Other: Methacholine Challenge Test
Other: Fractional Exhaled NO (FENO)
Other: Blood Test
Other: PCDAI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Methacholine challenge test [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    As assessed by methacholine challenge test with determination of PC20.


Secondary Outcome Measures:
  • Fractional Exhaled NO [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Exhaled NO test

  • Eosinophils count [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    blood test

  • Pediatric Crohn's Disease Activity Index (PCDAI) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Clinical Evaluation


Enrollment: 47
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297907

Locations
Israel
Rambam Medical Center
Haifa, Israel, 32000
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Prof. Lea Bentur, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01297907     History of Changes
Other Study ID Numbers: Crohn's
Study First Received: January 24, 2011
Last Updated: February 16, 2011
Health Authority: ISRAEL: Rambam Health Care Campus

Keywords provided by Rambam Health Care Campus:
Crohn's Disease
Bronchial hyper reactivity
Fractional exhaled NO
 Methacholine Challenge Test
Pediatric Crohn's Disease Activity Index
To determine the frequency of bronchial hyperreactivity in pediatric patients followed and treated for Crohn disease

Additional relevant MeSH terms:
Crohn Disease
Bronchial Hyperreactivity
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Bronchial Diseases
Respiratory Tract Diseases
Methacholine Chloride
Miotics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Therapeutic Uses
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013