Food AllergyINDYNCT02159833
Intranasal Diagnostics in Food Allergy: a Feasibility Study
A study testing Intranasal challenge with active substance (food protein) in people with Food Allergy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Intranasal challenge with active substance (food protein)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to 4 Jan 2019
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6 - 17 years old
- Physician-diagnosis of food allergy on the basis of:
- Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR
- History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR
- Evidence of >95% likelihood of food allergy (on the basis of serum specific IgE or skin prick test (SPT) 8mm or above to the causative food allergen within past 12 months
- Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. Participants aged over 16 years will need to provide their owned informed consent.
Who cannot join
- Contraindicated as acutely unwell or current unstable asthma:
- Acute wheeze in last 72 hours requiring treatment
- Febrile ≥38.0oC in last 72 hours
- Recent admission to hospital in last 2 weeks for acute asthma
- Current medication
- Use of asthma reliever medication in last 72 hours
- Recent administration of a medication containing antihistamine within the last 4 days
- Current oral steroid for asthma exacerbation or course completed within last 2 weeks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London / Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: Phase 1/2 Study to Determine the Intranasal Allergen Threshold to Food Proteins in Children With Food Allergy
The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.
- Conditions
- Food Allergy
- Being tested
- Intranasal challenge with active substance (food protein), Intranasal challenge with placebo
- Keywords
- Food allergy, Diagnosis
- Medical subject headings
- Food Hypersensitivity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal challenge with active substance (food protein)Other
Intranasal challenge with placeboOther
Also called placebo = 0.9% NaCl saline solution
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intranasal challenge with food protein or vehicle control Receives: Other: Intranasal challenge with active substance (food protein); Other: Intranasal challenge with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological response to intranasal challenge with a food protein
The physiological response to food (egg/cow's milk/soya/wheat/peanut) protein when administered into the human nasal airway in food-allergic children with the corresponding food allergy. This will be assessed objectively (using acoustic rhinometry and peak nasal inspiratory flow) as well as subjectively (using a validated Symptom Scoring questionnaire).
Measured: 20mins
Secondary outcomes (1)
Intranasal threshold to food protein
The intranasal threshold to food (egg/cow's milk/soya/wheat/peanut) protein to elicit a local physiological response in food-allergic children (with the corresponding food allergy), as defined by objective assessment described above.
Measured: 20 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startOct 2014
- Primary completion21 Dec 2018
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Paul J Turner, FRACP PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159833
- Sponsor's protocol ID
- 14SM2069
- Acronym
- INDY
- Status last verified
- Mar 2024
- First submitted
- 3 Jun 2014
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study to Determine the Intranasal Allergen Threshold to Food Proteins in Children With Food Allergy
- ClinicalTrials.gov ID
- NCT02159833
- Acronym / sponsor ID
- INDY / 14SM2069
- Conditions
- Food Allergy
- Keywords
- Food allergy, Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Oct 2014 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 10 Jun 2014 (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.
The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Intranasal challenge with active substance (food protein), Other: Intranasal challenge with placeboIntranasal challenge with food protein or vehicle control |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 6 - 17 years old
- Physician-diagnosis of food allergy on the basis of:
- Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. Participants aged over 16 years will need to provide their owned informed consent.
Key exclusion criteria (8 listed)
- Contraindicated as acutely unwell or current unstable asthma:
- Current medication
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 |
|---|---|---|
| Intranasal challenge with active substance (food protein) | Other | Intervention |
| Intranasal challenge with placeboAlso: placebo = 0.9% NaCl saline solution | Other | Intervention |
Primary outcome
Physiological response to intranasal challenge with a food protein
Time frame: 20mins
The physiological response to food (egg/cow's milk/soya/wheat/peanut) protein when administered into the human nasal airway in food-allergic children with the corresponding food allergy. This will be assessed objectively (using acoustic rhinometry and peak nasal inspiratory flow) as well as subjectively (using a validated Symptom Scoring questionnaire).
1 secondary outcome
Intranasal threshold to food protein
Time frame: 20 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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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.
Paul J Turner, FRACP PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal challenge with active substance (food protein) in people with Food Allergy, run by Imperial College London at 1 site in United Kingdom.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 28 Mar 2024. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological response to intranasal challenge with a food protein (time frame: 20mins). 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 28 Mar 2024.