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Bronchial Hyperreactivity in Children With Crohn Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297907
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  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:


Further study details as provided by Rambam Health Care Campus:

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


Secondary Outcome Measures:
  • Fractional Exhaled NO [ Time Frame: Day 1 ]
    Exhaled NO test

  • Eosinophils count [ Time Frame: Day 1 ]
    blood test

  • Pediatric Crohn's Disease Activity Index (PCDAI) [ Time Frame: Day 1 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297907


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

Responsible Party: Prof. Lea Bentur, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01297907     History of Changes
Other Study ID Numbers: Crohn's
First Submitted: January 24, 2011
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
Last Verified: October 2007

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
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action