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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Genetic and Rare Diseases Information Center resources: Pediatric 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 ]
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

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