NCT02884583

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 6, 2017

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

July 18, 2016

Last Update Submit

November 2, 2017

Conditions

Food Allergy SuspectedFood Allergy Proved

Keywords

Food allergyasthmaPredictive factorExacerbationPrevalence

Outcome Measures

Primary Outcomes (1)

  • Number of patient with bronchospasm in OFC

    up to 3 hours

Secondary Outcomes (7)

  • Questionnaire for the assessment of the responsible food of allergy

    up to 3 hours

  • the eliciting dose

    up to 3 hours

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

    up to 3 hours

  • The presence of one or several sensitisations associated with respiratory allergens

    up to 3 hours

  • The level of specific immunoglobulin E of the concerned food

    up to 3 hours

  • +2 more secondary outcomes

Study Arms (1)

Pulmonary function test

EXPERIMENTAL

Patients hospitalized for Oral Food Challenge realize pulmonary function test

Other: Pulmonary function test

Interventions

Pulmonary function testOTHER

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.

Pulmonary function test

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient hospitalized for oral food challenge at the hospital

You may not qualify if:

  • Patient want to leave the protocol
  • Patient take medication forbidden during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Food HypersensitivityAsthma

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Hypersensitivity

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 31, 2016

Study Start

April 26, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 6, 2017

Record last verified: 2016-08

Locations

FR(1)