Bronchial Hyperreactivity in Children With Crohn Disease - Full Text View

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 ] [ 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 (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

ClinicalTrials.gov processed this record on September 30, 2016