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Association Between Asthma and Food Allergy (AAAli)

Primary Purpose

Food Allergy Suspected, Food Allergy Proved

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Pulmonary function test

About this trial

This is an interventional diagnostic trial for Food Allergy Suspected focused on measuring Food allergy, asthma, Predictive factor, Exacerbation, Prevalence

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University hospital of MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary function test

Arm Description

Patients hospitalized for Oral Food Challenge realize pulmonary function test

Outcomes

Primary Outcome Measures

Number of patient with bronchospasm in OFC

Secondary Outcome Measures

Questionnaire for the assessment of the responsible food of allergy

the eliciting dose

the dose of the tested food which elicits the symptoms of allergy

The grade of the allergic reaction shown during the last food ingestion of the concerned food

The presence of one or several sensitisations associated with respiratory allergens

defining the atopic ground

The level of specific immunoglobulin E of the concerned food

The time of appearance of the first signs of atopy

questionnaire for the assessment of the mode of clinical expression of food allergies

Full Information

NCT ID

NCT02884583

First Posted

July 18, 2016

Last Updated

November 2, 2017

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02884583

Brief Title

Association Between Asthma and Food Allergy

Acronym

AAAli

Official Title

Association Between Asthma and Food Allergy in Children and Adults

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 26, 2016 (Actual)

Primary Completion Date

March 2018 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food Allergy Suspected, Food Allergy Proved

Keywords

Food allergy, asthma, Predictive factor, Exacerbation, Prevalence

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pulmonary function test

Arm Type

Experimental

Arm Description

Patients hospitalized for Oral Food Challenge realize pulmonary function test

Intervention Type

Other

Intervention Name(s)

Pulmonary function test

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of patient with bronchospasm in OFC

Time Frame

up to 3 hours

Secondary Outcome Measure Information:

Title

Questionnaire for the assessment of the responsible food of allergy

Time Frame

up to 3 hours

Title

the eliciting dose

Description

the dose of the tested food which elicits the symptoms of allergy

Time Frame

up to 3 hours

Title

The grade of the allergic reaction shown during the last food ingestion of the concerned food

Time Frame

up to 3 hours

Title

The presence of one or several sensitisations associated with respiratory allergens

Description

defining the atopic ground

Time Frame

up to 3 hours

Title

The level of specific immunoglobulin E of the concerned food

Time Frame

up to 3 hours

Title

The time of appearance of the first signs of atopy

Time Frame

up to 3 hours

Title

questionnaire for the assessment of the mode of clinical expression of food allergies

Time Frame

up to 3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University hospital of Montpellier

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal Demoly, MD, PhD

pascal.demoly@inserm.fr

First Name & Middle Initial & Last Name & Degree

Pascal DEMOLY, MD,PhD

First Name & Middle Initial & Last Name & Degree

Anca CHIRIAC, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Association Between Asthma and Food Allergy

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