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Bronchial Hyperreactivity in Children With Crohn Disease
This study has been completed.
Sponsor:
Rambam Health Care Campus
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01297907
First received: January 24, 2011
Last updated: February 16, 2011
Last verified: October 2007
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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
U.S. FDA Resources
Further study details as provided by Rambam Health Care Campus:
Primary Outcome Measures:
- Methacholine challenge test [ Time Frame: 18 months ]As assessed by methacholine challenge test with determination of PC20.
Secondary Outcome Measures:
- Fractional Exhaled NO [ Time Frame: Day 1 ]Exhaled NO test
- Eosinophils count [ Time Frame: Day 1 ]blood test
- Pediatric Crohn's Disease Activity Index (PCDAI) [ Time Frame: Day 1 ]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) |
| 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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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
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 |
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 June 23, 2017