Bronchial Hyperreactivity in Children With Crohn Disease

Crohn's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297907
• Other study ID #: Crohn's
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: February 16, 2011
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2007
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: ISRAEL: Rambam Health Care Campus
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 25 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchial Hyperreactivity
• Crohn Disease
• Crohn's Disease

Intervention

Other:
• Methacholine Challenge Test
Methacholine challenge test to evaluate airway hyperreactivity
• Fractional Exhaled NO (FENO)
Fractional Exhaled NO to evaluate eosinophilic inflammation
• Blood Test
Blood Tests (Eosinophil Count)
• PCDAI
Clinical Evaluation for Pediatric Crohn's Disease Activity Index (PCDAI)

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methacholine challenge test	As assessed by methacholine challenge test with determination of PC20.	18 months	Yes
Secondary	Fractional Exhaled NO	Exhaled NO test	Day 1	No
Secondary	Eosinophils count	blood test	Day 1	No
Secondary	Pediatric Crohn's Disease Activity Index (PCDAI)	Clinical Evaluation	Day 1	No