Food Allergy SuspectedAAAliNCT02884583
Association Between Asthma and Food Allergy
A study testing Pulmonary function test in people with Food Allergy Suspected and Food Allergy Proved, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Food Allergy Suspected, Food Allergy Proved
- What is being tested?
- Pulmonary function test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2016to Mar 2018
- Phase
- Interventional
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient hospitalized for oral food challenge at the hospital
Who cannot join
- Patient want to leave the protocol
- Patient take medication forbidden during the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital of Montpellier
Montpellier, 34295
Pascal Demoly, MD, PhD, pascal.demoly@inserm.fr
Pascal DEMOLY, MD,PhD
About this study
Official title: 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.
- Conditions
- Food Allergy Suspected, Food Allergy Proved
- Being tested
- Pulmonary function test
- Keywords
- Food allergy, asthma, Predictive factor, Exacerbation, Prevalence
- Medical subject headings
- Food Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary function test | Experimental | Patients hospitalized for Oral Food Challenge realize pulmonary function test Receives: Other: Pulmonary function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with bronchospasm in OFC
Measured: up to 3 hours
Secondary outcomes (7)
Questionnaire for the assessment of the responsible food of allergy
Measured: up to 3 hours
the eliciting dose
the dose of the tested food which elicits the symptoms of allergy
Measured: up to 3 hours
The grade of the allergic reaction shown during the last food ingestion of the concerned food
Measured: up to 3 hours
The presence of one or several sensitisations associated with respiratory allergens
defining the atopic ground
Measured: up to 3 hours
The level of specific immunoglobulin E of the concerned food
Measured: up to 3 hours
The time of appearance of the first signs of atopy
Measured: up to 3 hours
questionnaire for the assessment of the mode of clinical expression of food allergies
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start26 Apr 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy SuspectedStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884583
- Sponsor's protocol ID
- 9613
- Acronym
- AAAli
- Status last verified
- Aug 2016
- First submitted
- 18 Jul 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Asthma and Food Allergy in Children and Adults
- ClinicalTrials.gov ID
- NCT02884583
- Acronym / sponsor ID
- AAAli / 9613
- Conditions
- Food Allergy Suspected, Food Allergy Proved
- Keywords
- Food allergy, asthma, Predictive factor, Exacerbation, Prevalence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 31 Aug 2016 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary function test | Experimental | Other: Pulmonary function testPatients hospitalized for Oral Food Challenge realize pulmonary function test |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient hospitalized for oral food challenge at the hospital
Key exclusion criteria (2 listed)
- Patient want to leave the protocol
- Patient take medication forbidden during the study
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 |
|---|---|---|
| Pulmonary function testPatients 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. | Other | Pulmonary function test |
Primary outcome
Number of patient with bronchospasm in OFC
Time frame: up to 3 hours
7 secondary outcomes
Questionnaire for the assessment of the responsible food of allergy
Time frame: up to 3 hours
the eliciting dose
Time frame: 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
The presence of one or several sensitisations associated with respiratory allergens
Time frame: up to 3 hours
The level of specific immunoglobulin E of the concerned food
Time frame: up to 3 hours
The time of appearance of the first signs of atopy
Time frame: up to 3 hours
questionnaire for the assessment of the mode of clinical expression of food allergies
Time frame: up to 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary function test in people with Food Allergy Suspected and Food Allergy Proved, run by University Hospital, Montpellier at 1 site in France.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Nov 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with bronchospasm in OFC (time frame: up to 3 hours). 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 6 Nov 2017.