Bronchial Hyperreactivity in Children With Crohn Disease

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment
Crohn's Disease	Other: Methacholine Challenge Test; Other: Fractional Exhaled NO (FENO); Other: Blood Test; Other: PCDAI

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	47 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Study Start Date :	May 2008
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	December 2009

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Methacholine challenge test [ Time Frame: 18 months ]
   As assessed by methacholine challenge test with determination of PC20.

Secondary Outcome Measures :

1. Fractional Exhaled NO [ Time Frame: Day 1 ]
   Exhaled NO test
2. Eosinophils count [ Time Frame: Day 1 ]
   blood test
3. Pediatric Crohn's Disease Activity Index (PCDAI) [ Time Frame: Day 1 ]
   Clinical Evaluation

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Rambam Medical Center
Haifa, Israel, 32000

Sponsors and Collaborators

Rambam Health Care Campus

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 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