- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02884583
Association Between Asthma and Food Allergy (AAAli)
Association Between Asthma and Food Allergy in Children and Adults
Prevalences of food allergies and asthma increased in the population during the last decades. These two pathologies, responsible for a real burden, are often associated and are to be considered as comorbidities; this aspect is more and more studied in the literature and many authors tried to find a link between diets and asthma. The narrow link between these two atopic pathologies and the fact that food allergy can come along with respiratory symptoms also in patients without history of asthma must be better understood, considered into the management of food allergy. The main objective of this study is to study the prevalence of signs and/or symptoms suggestive of bronchial hyperreactivity, during an oral food challenge (OFC) in patients older than 5 years. The secondary objective is to study the risk factors to develop asthma during a food allergy reaction.
This historical-prospective single center study , was realized in the Allergy Unit of the University Hospital of Montpellier. All the patients having been hospitalized for a positive OFC between January, 2001 and January, 2016 were included. The diagnosis of asthma was established according to the recommended international clinical and physiological criteria. Prevalence of bronchial hyperreactivity during OFC among those with positive OFC, was calculated. The search for risk factors was made by a logistic regression univariate then multivariate, completed by a decision tree.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34295
- Recruiting
- University Hospital of Montpellier
-
Contact:
- Pascal Demoly, MD, PhD
- Email: pascal.demoly@inserm.fr
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Principal Investigator:
- Pascal DEMOLY, MD,PhD
-
Sub-Investigator:
- Anca CHIRIAC, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient hospitalized for oral food challenge at the hospital
Exclusion Criteria:
- Patient want to leave the protocol
- Patient take medication forbidden during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pulmonary function test
Patients hospitalized for Oral Food Challenge realize pulmonary function test
|
Patients hospitalized for OFC realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes) and static volume assessment, by using body plethysmography, were realized before, during and after the OFC.
An exhaled fraction of NO (FeNO) is also realized to characterize asthma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patient with bronchospasm in OFC
Time Frame: up to 3 hours
|
up to 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire for the assessment of the responsible food of allergy
Time Frame: up to 3 hours
|
up to 3 hours
|
|
the eliciting dose
Time Frame: up to 3 hours
|
the dose of the tested food which elicits the symptoms of allergy
|
up to 3 hours
|
The grade of the allergic reaction shown during the last food ingestion of the concerned food
Time Frame: up to 3 hours
|
up to 3 hours
|
|
The presence of one or several sensitisations associated with respiratory allergens
Time Frame: up to 3 hours
|
defining the atopic ground
|
up to 3 hours
|
The level of specific immunoglobulin E of the concerned food
Time Frame: up to 3 hours
|
up to 3 hours
|
|
The time of appearance of the first signs of atopy
Time Frame: up to 3 hours
|
up to 3 hours
|
|
questionnaire for the assessment of the mode of clinical expression of food allergies
Time Frame: up to 3 hours
|
up to 3 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9613
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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