Anaphylaxis Food
Conditions
Brief summary
Study Objective To evaluate the efficacy of FMXIN002, a powder-based intranasal epinephrine spray, for treating anaphylaxis. Study Design • Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more rapidly-than IM epinephrine, as measured by clinical parameters.
Detailed description
Study Procedures 1. Informed Consent: Participants will sign consent forms. 2. Food Challenge: Subjects will undergo routine diagnostic oral food challenges (OFC) relevant to their suspected allergens. 3. Assessment: At the first signs of allergic symptoms, a physician will assess the subject. 4. Treatment Criteria: If a Grade II or III anaphylactic reaction occurs, the participant will receive either: A). Intranasal spray of epinephrine FMXIN002 4mg + placebo saline injection B). Intranasal spray of placebo + intramuscular epinephrine injection (Adrenalin 0.5mg) One administration will always be epinephrine; the other, placebo. 5. Randomization: 1:1 between the 2 study arms. 6. Exclusion from Trial Treatment: Severe reactions or physician discretion may warrant standard care (IM epinephrine 0.5 mg) without study drug. 7. Blinding: Double-blinded setup with pre-prepared, numbered envelopes containing randomized treatment kits (nasal spray + injection). 8. Supportive Treatment: All participants will receive antihistamines (Fenistil drops + fexofenadine 180 mg or desloratadine 5 mg). Inhaled bronchodilators (e.g., Ventolin) will be provided for respiratory symptoms as needed. 9. Monitoring: Assessments at baseline, symptom onset, and at 3, 5, 10, 15, 30, and 90 minutes post-treatment. Vital signs and system-based symptom assessments will be recorded (Appendix 3). 10. Rescue Therapy: If no improvement in 3-5 minutes, a second IM epinephrine dose (0.5 mg) will be given. Further treatment will follow standard anaphylaxis protocols 11. Discharge: Participants with symptom resolution by 90 minutes will be discharged.
Interventions
COMBINATION_PRODUCTEpinephrine 4mg nasal powder spray
Epinephrine nasal powder spray in a unidose nasal applicator device. Will be administered together with a placebo saline IM injection
COMBINATION_PRODUCTAdrenalin 0.5mg Injectable Product
Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray.
Sponsors
Nasus Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-40 years, any gender * Documented or suspected food allergy (based on IgE level or clinical history) * Development of Grade II or III reaction during OFC
Exclusion criteria
* Age \<18 or \>40 * Poorly controlled asthma (FEV1 \< 80% or frequent symptoms) * Active eosinophilic esophagitis * Pregnancy or risk of pregnancy * Mild (Grade I) or very severe (Grade IV) reactions during OFC * Decline to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs: oxygen saturation | 0-90 minutes after drug administration | % oxygen saturation measurement using oxygen monitor |
| Vital signs: Blood pressure | 0-90 minutes after drug administration | Systolic and diastolic blood pressure by a blood pressure cuff |
| Vital signs: pulse rate | 0-90 minutes after drug administration | heart rate by pulse rate measurement |
| Skin system anaphylaxis symptoms | 0-90 minutes after drug administration | Severity grading system for acute allergic reactions. Skin system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021 |
| Mucosal system anaphylaxis symptoms | 0-90 minutes after drug administration | Severity grading system for acute allergic reactions, mucosal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021 |
| Gastrointestinal system anaphylaxis symptoms | 0-90 minutes after drug administration | Severity grading system for acute allergic reactions, gastrointestinal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021. |
| Respiratory system anaphylaxis symptoms | 0-90 minutes after drug administration | Severity grading system for acute allergic reactions, respiratory system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021. |
| Total anaphylaxis severity score | 0-90 minutes after drug administration | Severity grading system for acute allergic reactions, Combined systems, anaphylaxis score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 0-90 minutes after drug administration | Any treatment-related adverse events |
| Need for a second epinephrine dose | 0-90 minutes after drug administration | Number of patients needed a second dose, by Adrenalin IM injection |
Countries
Israel
Outcome results
None listed