FMXIN002 in Patients at Risk of Anaphylaxis

Overview

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.

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.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes