Crohn's DiseaseNCT01297907
Bronchial Hyperreactivity in Children With Crohn Disease
An observational study of Crohn's Disease, run by Rambam Health Care Campus at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 6 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Methacholine Challenge Test, Fractional Exhaled NO (FENO) and Blood Test
- How many people
- 47 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Twenty-three children with Crohn disease in the age of 11 to 22 yr
Who may be able to join
- Children with Crohn disease
- Children that can perform lung function tests (MCT)
Who cannot join
- Upper respiratory tract infection last month
- Fever or Pneumonia last month
- Smoking
- Other chronic diseases
- Other respiratory diseases
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Methacholine Challenge Test, Fractional Exhaled NO (FENO), Blood Test, PCDAI
- 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
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine Challenge TestOther
Methacholine challenge test to evaluate airway hyperreactivity
Fractional Exhaled NO (FENO)Other
Fractional Exhaled NO to evaluate eosinophilic inflammation
Blood TestOther
Blood Tests (Eosinophil Count)
PCDAIOther
Clinical Evaluation for Pediatric Crohn's Disease Activity Index (PCDAI)
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Patients | Random Crohn's Disease Patients that can perform Methacholine Challenge Test (MCT) Receives: 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) Receives: Other: Methacholine Challenge Test; Other: Fractional Exhaled NO (FENO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine challenge test
As assessed by methacholine challenge test with determination of PC20.
Measured: 18 months
Secondary outcomes (3)
Fractional Exhaled NO
Exhaled NO test
Measured: Day 1
Eosinophils count
blood test
Measured: Day 1
Pediatric Crohn's Disease Activity Index (PCDAI)
Clinical Evaluation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297907
- Sponsor's protocol ID
- Crohn's
- Status last verified
- Oct 2007
- First submitted
- 24 Jan 2011
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Hyperreactivity in Children With Crohn Disease
- ClinicalTrials.gov ID
- NCT01297907
- Acronym / sponsor ID
- Crohn's
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's Patients | – | Other: Methacholine Challenge Test, Other: Fractional Exhaled NO (FENO), Other: Blood Test, Other: PCDAIRandom Crohn's Disease Patients that can perform Methacholine Challenge Test (MCT) |
| Negative MCT | – | Other: Methacholine Challenge Test, Other: Fractional Exhaled NO (FENO)Patients evaluated for functional cough who had negative Methacholine Challenge Test (MCT) |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Twenty-three children with Crohn disease in the age of 11 to 22 yr
Key inclusion criteria (2 listed)
- Children with Crohn disease
- Children that can perform lung function tests (MCT)
Key exclusion criteria (5 listed)
- Upper respiratory tract infection last month
- Fever or Pneumonia last month
- Smoking
- Other chronic diseases
- Other respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methacholine Challenge TestMethacholine challenge test to evaluate airway hyperreactivity | Other | Crohn's Patients, Negative MCT |
| Fractional Exhaled NO (FENO)Fractional Exhaled NO to evaluate eosinophilic inflammation | Other | Crohn's Patients, Negative MCT |
| Blood TestBlood Tests (Eosinophil Count) | Other | Crohn's Patients |
| PCDAIClinical Evaluation for Pediatric Crohn's Disease Activity Index (PCDAI) | Other | Crohn's Patients |
Primary outcome
Methacholine challenge test
Time frame: 18 months
As assessed by methacholine challenge test with determination of PC20.
3 secondary outcomes
Fractional Exhaled NO
Time frame: Day 1
Eosinophils count
Time frame: Day 1
Pediatric Crohn's Disease Activity Index (PCDAI)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methacholine challenge test (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011.