Bronchial Hyperreactivity in Children With Crohn Disease
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ClinicalTrials.gov Identifier: NCT01297907 |
Recruitment Status :
Completed
First Posted : February 17, 2011
Last Update Posted : February 17, 2011
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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 |
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Crohn's Disease | Other: Methacholine Challenge Test Other: Fractional Exhaled NO (FENO) Other: Blood Test Other: PCDAI |
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 |

Group/Cohort | Intervention/treatment |
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Crohn's Patients
Random Crohn's Disease Patients that can perform Methacholine Challenge Test (MCT)
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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)
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Other: Methacholine Challenge Test
Methacholine challenge test to evaluate airway hyperreactivity Other: Fractional Exhaled NO (FENO) Fractional Exhaled NO to evaluate eosinophilic inflammation |
- Methacholine challenge test [ Time Frame: 18 months ]As assessed by methacholine challenge test with determination of PC20.
- 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

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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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297907
Israel | |
Rambam Medical Center | |
Haifa, Israel, 32000 |
Responsible Party: | Prof. Lea Bentur, Rambam Health Care Campus |
ClinicalTrials.gov Identifier: | NCT01297907 |
Other Study ID Numbers: |
Crohn's |
First Posted: | February 17, 2011 Key Record Dates |
Last Update Posted: | February 17, 2011 |
Last Verified: | October 2007 |
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 |
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 |