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Enrolling by invitation NCT07045701

FMXIN002 in Patients at Risk of Anaphylaxis

Phase II / Phase III Interventional Anaphylaxis Food

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epinephrine 4mg nasal powder spray, Adrenalin 0.5mg Injectable Product.
Who it may be relevant to
Registry conditions: Anaphylaxis Food. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of FMXIN002 Epinephrine Powder Nasal Spray for the Treatment of Acute Allergic Reactions 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.

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 product Epinephrine 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 product Adrenalin 0.5mg Injectable Product
    Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray.

Primary outcome measures

  • Skin system anaphylaxis symptoms [Time frame: 0-90 minutes after drug administration]
  • Mucosal system anaphylaxis symptoms [Time frame: 0-90 minutes after drug administration]
  • Gastrointestinal system anaphylaxis symptoms [Time frame: 0-90 minutes after drug administration]
  • Respiratory system anaphylaxis symptoms [Time frame: 0-90 minutes after drug administration]
  • Total anaphylaxis severity score [Time frame: 0-90 minutes after drug administration]
  • Vital signs: Blood pressure [Time frame: 0-90 minutes after drug administration]
  • Vital signs: pulse rate [Time frame: 0-90 minutes after drug administration]
  • Vital signs: oxygen saturation [Time frame: 0-90 minutes after drug administration]
Secondary outcome measures (2)
  • Need for a second epinephrine dose [Time frame: 0-90 minutes after drug administration]
  • Adverse events [Time frame: 0-90 minutes after drug administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Shamir Medical Center — Be’er Ya‘aqov

Identifiers

NCT: NCT07045701 · NP-009-Epinephrine

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗