Food Allergy Diagnostic Test Response to Previous Oral Challenge Response

NCT03693456 | Completed

• 1 other identifier: ORA-FA-002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the ocular response to CAC (using food allergen sensitive patients) to the systemic response of a previously performed oral food allergen challenge in the same subjects. This study will investigate the potential utility of CAC as a predictive tool for identifying patient response to food allergen challenge and maximum tolerated dose.

Conditions

Food Hypersensitivity

Outcome Measures

Primary Outcomes (3)

• Ora Calibra Ocular Itching Scale

  Ten minutes after each CAC dose through duration of challenge (up to 90 minutes)

• Ora Calibra Ocular Hyperemia Scale

  Ten minutes after each CAC dose through duration of challenge (up to 90 minutes)

• Ora Calibra Itchy Palate/Mouth Scale

  Ten minutes after each CAC dose through duration of challenge (up to 90 minutes)

Study Arms (3)

Responders Without Epinephrine

EXPERIMENTAL

Subjects experienced a positive response during previous oral food challenge without a severe adverse event and did not require epinephrine. Will be subjected to a conjunctival allergen challenge.

Other: Conjunctival Allergen Challenge

Responders With Epinephrine

EXPERIMENTAL

Subjects experienced a positive response during previous oral food challenge and required epinephrine. Will be subjected to a conjunctival allergen challenge.

Other: Conjunctival Allergen Challenge

Non-Responders

EXPERIMENTAL

Subjects did not experience a positive response during previous oral food challenge. Will be subjected to a conjunctival allergen challenge.

Other: Conjunctival Allergen Challenge

Interventions

Conjunctival Allergen Challenge OTHER

Food allergen dissolved in water will be instilled in an increasing titrated fashion into the subjects eye and response will be graded according to proprietary scales.

Non-Responders; Responders With Epinephrine; Responders Without Epinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be male or female of any race, at least 5 years of age with documented food challenge in the past 12 months;
• Have provided verbal and written informed consent. If under 18, a parent/guardian must provide consent for the subject;
• Negative pregnancy test for women of childbearing potential;
• Be willing and able to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study;

You may not qualify if:

• Be a woman who is pregnant or nursing an infant;
• Be unable to discontinue short-acting antihistamines for three days or long-acting antihistamines for five to seven days (depending on half-life) prior to CAC;
• Have asthma that has evolved and now fulfills any of the criteria defined as follows:
• uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with combination therapy of medium dose inhaled corticosteroid with a long acting inhaled β2-agonists.
• at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months.
• prior intubation for asthma in the past year;
• Be receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy;
• Be receiving or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy;
• Be receiving or planning to receive any type of immunotherapy to any food (e.g. oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) during their participation in the study;
• Be receiving or planning to receive any aeroallergen immunotherapy during their participation in the study;
• Be suffering from generalized dermatologic disease (e.g. severe atopic dermatitis, uncontrolled generalized eczema, ichthyosis vulgaris);
• Have any new disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias;
• Have experienced severe anaphylaxis resulting in emergency hospitalization;

Sponsors & Collaborators

• ORA, Inc.: lead

Study Sites (1)

Allergy, Asthma & Immunology Relief (AAIR) of Charlotte

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Maeve E O'Connor, M.D.

  Allergy, Asthma & Immunology Relief (AAIR) of Charlotte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 3, 2018

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)