Association Between Asthma and Food Allergy (AAAli)

November 2, 2017 updated by: University Hospital, Montpellier

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

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montpellier, France, 34295
        • Recruiting
        • University Hospital of Montpellier
        • Contact:
        • Principal Investigator:
          • Pascal DEMOLY, MD,PhD
        • Sub-Investigator:
          • Anca CHIRIAC, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 26, 2016

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (ESTIMATE)

August 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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