Bronchial Hyperreactivity in Children With Crohn Disease

Completed

• Conditions: Crohn's Disease
• Interventions: Other: Methacholine Challenge Test; Other: Fractional Exhaled NO (FENO); Other: Blood Test; Other: PCDAI

• Registration Number: NCT01297907
• Lead Sponsor: Rambam Health Care Campus

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-10
• Study Start: 2008-05
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-02-16
• Last Update Submitted: 2011-02-16
• Study First Posted: 2011-02-17
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn's Patients	PCDAI	Random Crohn's Disease Patients that can perform Methacholine Challenge Test (MCT)
Negative MCT	Methacholine Challenge Test	Patients evaluated for functional cough who had negative Methacholine Challenge Test (MCT)
Crohn's Patients	Methacholine Challenge Test	Random Crohn's Disease Patients that can perform Methacholine Challenge Test (MCT)
Crohn's Patients	Blood Test	Random Crohn's Disease Patients that can perform Methacholine Challenge Test (MCT)
Crohn's Patients	Fractional Exhaled NO (FENO)	Random Crohn's Disease Patients that can perform Methacholine Challenge Test (MCT)
Negative MCT	Fractional Exhaled NO (FENO)	Patients evaluated for functional cough who had negative Methacholine Challenge Test (MCT)

Primary Outcome Measures

Name	Time	Method
Methacholine challenge test	18 months	As assessed by methacholine challenge test with determination of PC20.

Secondary Outcome Measures

Name	Time	Method
Fractional Exhaled NO	Day 1	Exhaled NO test
Eosinophils count	Day 1	blood test
Pediatric Crohn's Disease Activity Index (PCDAI)	Day 1	Clinical Evaluation

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel