Bronchial Hyperreactivity in Children With Crohn Disease

NCT01297907 | Completed DMC

• 1 other identifier: Crohn's
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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).

Conditions

Crohn's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Methacholine challenge test

  As assessed by methacholine challenge test with determination of PC20.

  18 months

Secondary Outcomes (3)

• Fractional Exhaled NO

  Day 1

• Eosinophils count

  Day 1

• Pediatric Crohn's Disease Activity Index (PCDAI)

  Day 1

Study Arms (2)

Crohn's Patients

Random Crohn's Disease Patients that can perform Methacholine Challenge Test (MCT)

Other: Methacholine Challenge Test; Other: Fractional Exhaled NO (FENO); Other: Blood Test; Other: PCDAI

Negative MCT

Patients evaluated for functional cough who had negative Methacholine Challenge Test (MCT)

Other: Methacholine Challenge Test; Other: Fractional Exhaled NO (FENO)

Interventions

Methacholine Challenge Test OTHER

Methacholine challenge test to evaluate airway hyperreactivity

Crohn's Patients; Negative MCT

Fractional Exhaled NO (FENO) OTHER

Fractional Exhaled NO to evaluate eosinophilic inflammation

Crohn's Patients; Negative MCT

Blood Test OTHER

Blood Tests (Eosinophil Count)

Crohn's Patients

PCDAI OTHER

Clinical Evaluation for Pediatric Crohn's Disease Activity Index (PCDAI)

Crohn's Patients

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Twenty-three children with Crohn disease in the age of 11 to 22 yr

You may qualify if:

• Children with Crohn disease
• Children that can perform lung function tests (MCT)

You may not qualify if:

• Upper respiratory tract infection last month
• Fever or Pneumonia last month
• Smoking
• Other chronic diseases
• Other respiratory diseases

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, 32000, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: February 17, 2011
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 17, 2011

Record last verified: 2007-10

Locations

IL (1)