Efficacy and Safety of FMXIN002 Epinephrine Powder Nasal Spray for the Treatment of Acute Allergic Reactions in Patients at Risk of Anaphylaxis
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Nasus Pharma
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Respiratory system anaphylaxis symptoms
研究概览
简要总结
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.
详细描述
Study Procedures
- Informed Consent: Participants will sign consent forms.
- Food Challenge: Subjects will undergo routine diagnostic oral food challenges (OFC) relevant to their suspected allergens.
- Assessment: At the first signs of allergic symptoms, a physician will assess the subject.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Respiratory system anaphylaxis symptoms
时间窗: 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.
Vital signs: pulse rate
时间窗: 0-90 minutes after drug administration
heart rate by pulse rate measurement
Skin system anaphylaxis symptoms
时间窗: 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
时间窗: 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
时间窗: 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.
Total anaphylaxis severity score
时间窗: 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.
Vital signs: Blood pressure
时间窗: 0-90 minutes after drug administration
Systolic and diastolic blood pressure by a blood pressure cuff
Vital signs: oxygen saturation
时间窗: 0-90 minutes after drug administration
% oxygen saturation measurement using oxygen monitor
Skin system anaphylaxis symptoms
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Vital signs: pulse rate
时间窗: 0-90 minutes after drug administration
heart rate by pulse rate measurement
Vital signs: oxygen saturation
时间窗: 0-90 minutes after drug administration
% oxygen saturation measurement using oxygen monitor
次要结局
- Adverse events(0-90 minutes after drug administration)
- Need for a second epinephrine dose(0-90 minutes after drug administration)
- Need for a second epinephrine dose(0-90 minutes after drug administration)