Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges
This study is exploring a new way to treat sudden and serious allergic reactions using inhaled adrenaline (epinephrine). These reactions can sometimes happen during common allergy procedures like allergy skin tests, treatments to build up your tolerance (immunotherapy), or tests where you eat small amounts of a food or drug to see if you're allergic (oral challenges). The main goal is to see how well this inhaled medicine works for people who experience these reactions. This is a small, early-stage study (Phase 1) and will involve up to 100 people across multiple centres. It's particularly looking at individuals who may not be suitable for another larger study (GHL-101) but still need options to manage their allergies safely.
At a glance
What is this study about?
This research study is looking into a new way to help people who have serious allergic reactions. These reactions, sometimes called anaphylaxis, can be very serious and might happen unexpectedly during allergy testing, when you're getting allergy shots, or while doing food or medication challenges (where you slowly try a tiny bit of something you might be allergic to).
The study wants to find out if giving a special inhaled form of adrenaline (epinephrine) can help calm these reactions down quickly. Adrenaline is a well-known medicine used to treat severe allergies, but this study is testing if breathing it in through an inhaler is effective and safe. This could be a new, easier way to treat reactions compared to injections. This is an early-stage study, meaning we're still learning a lot about this new approach.
The main reason this study is important is to find better and more convenient ways to manage allergic reactions, especially for people who might not be able to take part in other ongoing research. If successful, an inhaled form of adrenaline could offer another valuable tool for both patients and healthcare providers to quickly respond to allergic emergencies, making allergy testing and treatment safer.
Key takeaways
- This study is testing an inhaled form of adrenaline for allergic reactions.
- It focuses on reactions during allergy tests, shots, or food/drug challenges.
- It's an early-stage study for people aged 12 and over.
- Participation lasts about one week.
- Aims to find new, easier ways to treat serious allergies.
Who may be eligible?
This study is looking for both men and women aged 12 years and older who have known or suspected allergies. To join, you should have either a confirmed allergy (like a positive skin test) or a strong history of allergic reactions.
You would also need to have recently experienced a significant allergic reaction (Grade 2 or higher) during allergy testing, allergy shots, or a food/drug challenge, and your doctor believes you are a good fit for this study. Women who could get pregnant must agree to use effective birth control throughout the study, and you cannot be pregnant or breastfeeding.
You can't join if you've had a bad reaction to adrenaline before, or if you have certain existing health conditions or very abnormal blood pressure or heart rate. You also can't be taking part in another drug study at the same time or have been in this specific study before.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 12 years old or older?
- Do you have known or suspected allergies?
- Have you recently had a significant allergic reaction during allergy testing or treatment?
- Are you able to use reliable birth control if you are a woman of childbearing potential?
- Have you *not* had a bad reaction to adrenaline before?
- Are you *not* currently in another drug study?
What does participation involve?
If you decide to take part in this study, your involvement would be quite short – usually around one week in total. During this time, you would attend a few appointments at the study clinic. The main focus of the study is to evaluate the inhaled adrenaline during an allergic reaction. You will be closely monitored by medical staff. You won't have to take any long-term medication for this study, and there won't be many follow-up visits after the initial assessment. The overall aim is to observe how your body responds to the inhaled medication if you experience a reaction, under careful medical supervision.
Potential risks and benefits
Locations (1)
- Kokua Pharma Inc.Verified postcodeRichmond, Canada· Recruiting
Common questions
What is an 'allergic reaction' in this study?
In this study, an allergic reaction means a significant body-wide reaction (Grade 2 or higher) that happens during allergy testing, allergy shots, or food/drug challenges.
What is adrenaline (epinephrine)?
Adrenaline is a medicine commonly used to treat severe allergic reactions. This study explores a new way to give it – by breathing it in.
How long will I be involved in the study?
Your participation in the study is expected to last for about one week in total.
Can children join this study?
Yes, individuals aged 12 years and older can take part in this study.
Will I get paid to be in the study?
The information provided does not state whether participants will be compensated for their involvement.
How to find out more
George H. Luciuk, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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