Bronchial Hyperreactivity in Children With Crohn Disease | NCT01297907

Studies
Bronchial Hyperreactivity in Children With Crohn Disease

NCT01297907

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Feb 17, 2011Estimated

Enrollment

47Actual

Phase

Not provided

Conditions

Crohn's Disease

Interventions

Methacholine Challenge Test
Fractional Exhaled NO (FENO)
Blood Test
PCDAI

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jan 24, 2011

First Submission Date that Met QC Criteria

Feb 16, 2011

First Posted Date

Feb 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2011

Last Update Posted Date

Feb 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Methacholine Challenge Test	Other	Methacholine challenge test to evaluate airway hyperreactivity	Crohn's Patients Negative MCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Methacholine challenge test	As assessed by methacholine challenge test with determination of PC20.	18 months

Secondary Outcomes

Measure	Description	Time Frame
Fractional Exhaled NO	Exhaled NO test	Day 1
Eosinophils count	blood test	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center		Haifa		32000	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided