A Phase 1b, Open-Label, Exploratory Study Evaluating the Effects of Inhaled Epinephrine in Individuals Experiencing Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time to resolution of systemic symptoms
研究概览
简要总结
The goal of this exploratory study is to evaluate the effects of inhaled epinephrine in subjects, who may not be eligible for the GHL-101 trial, and who are experiencing systemic allergic reaction (SAR) that occur following allergy testing, subcutaneous immunotherapy (SCIT), oral challenges (with food and/or drug) or oral immunotherapy (OIT).
详细描述
This is a Phase 1b, multi-center, open label exploratory study evaluating the effects of inhaled epinephrine in patients who are undergoing planned allergy testing, SCIT, oral challenges (with food and/or drug), or OIT and are not eligible for the GHL-101 study. This study will enroll and dose up to 100 patients.
The maximum duration of subject participation is approximately 1 week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, aged ≥ 12 years with known or suspected allergen sensitivity who can also have a clinical history of immunoglobulin E (IgE)-mediated allergy, including a documented sensitivity to allergens (i.e., positive skin prick test, or positive in vitro serum IgE).
- •Have undergone either a) allergy testing for suspected sensitivity/allergy, b) future oral challenge (food and/or drug) or future OIT to treat existing allergies or c) SCIT AND experienced a SAR Grade 2 or higher, following allergy testing, SCIT, or oral challenges (food and/or drug) for future OIT, and deemed eligible for enrollment by the Principal Investigator.
- •For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception* method between Screening and End-of-Study Visits.
排除标准
- •Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
- •Known history or presence of clinically disease/condition that could confound the results of the study or place the subject at undue or additional risk per the judgment of the Investigator.
- •Abnormal vital signs at screening (i.e., systolic blood pressure: < 90 or >140 mmHg, diastolic blood pressure: < 40 or > 90 mmHg or, heart rate: < 45 or > 100 bpm), respiration rate < 8 or > 20 resp./min.
- •Females who are pregnant, plan to become pregnant or lactating.
- •Participation in another clinical study involving an investigational drug within 30 days prior to screening, an investigational biologic within 60 days prior to screening, or current/planned participation in another interventional study during this study.
- •Previous treatment in this study.
- •Any other reason that, in the opinion of the Investigator, is likely to unfavorably alter subject risk-benefit, confound results, or make it difficult for the subject to fully comply with study requirements.
研究组 & 干预措施
Inhaled Epinephrine
The first inhalation will be administered as soon as possible (i.e., within approximately 30 seconds) following identification of a SAR Grade 2 or higher and confirmation of enrollment by the Principal Investigator. The second inhalation will be administered approximately 10 seconds later, and the subject will be observed for approximately 2 minutes for signs of symptom resolution.
Inhalations will continue in this manner until either:
- resolution of systemic symptoms (defined as a reduction in SAR Grade to ≤1), or
- if maximum number of inhalations (8 inhalations) has not been reached, complete resolution of systemic symptoms (defined as reduction in SAR Grade to 0) without exceeding maximum 8 inhalations, or
- administration of intra-muscular epinephrine, whichever occurs earlier.
If a recurrence of symptoms is observed, administration may continue until a maximum of 8 inhalations is reached.
干预措施: Inhaled Epinephrine (Drug)
结局指标
主要结局
Time to resolution of systemic symptoms
时间窗: From first dose administration to 60 minutes following first dose administration
Defined as a reduction in systemic allergic reaction (SAR) Grade to ≤ 1. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.
Time to complete resolution of systemic symptoms
时间窗: From first dose administration to 60 minutes following first dose administration
Defined as a reduction in systemic allergic reaction (SAR) Grade to 0. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.
Time to resolution of systemic symptoms
时间窗: From first dose administration to 60 minutes following first dose administration
Defined as a reduction in systemic allergic reaction (SAR) Grade to ≤ 1. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.
Time to complete resolution of systemic symptoms
时间窗: From first dose administration to 60 minutes following first dose administration
Defined as a reduction in systemic allergic reaction (SAR) Grade to 0. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.
次要结局
未报告次要终点
研究者
Dr. George Luciuk
President, Chief Medical Officer
Kokua Pharma Inc.