An open-label, crossover trial in otherwise healthy volunteers with allergic rhinitis to evaluate the relative bioavailability and hemodynamic effects of OX640 nasal epinephrine powder to a marketed epinephrine intramuscular injection
This study is looking into a new type of medicine delivery: an epinephrine (adrenaline) nose spray, called OX640. Epinephrine is used to treat severe allergic reactions, called anaphylaxis. Researchers want to see how well this nose spray delivers the medicine into the body compared to the usual epinephrine injection. They also want to check how it affects important body functions like blood pressure and heart rate. It's a very early-stage study, meaning it's primarily focused on safety and how the medicine works in the body. The study involves healthy volunteers who have allergic rhinitis (like hay fever) but are otherwise well.
At a glance
What is this study about?
This research is investigating a new way to give adrenaline (a medicine also known as epinephrine) for people who have severe allergic reactions, called anaphylaxis. Currently, adrenaline is usually given as an injection, often with a device called an auto-injector (like an EpiPen). The new method being tested is a nose spray.
The main goal of this study is to see how well the new adrenaline nose spray gets the medicine into the body compared to the standard injection. They want to understand if the nose spray delivers enough medicine quickly and effectively. They will also be carefully checking how the nose spray affects a person's heart and blood pressure to make sure it's safe.
This is a very early stage of research, often called a Phase 1 study. This means it's primarily about understanding how the medicine works in the human body and checking its safety, rather than treating an illness. The results will help researchers decide if this new nose spray is promising enough to test in larger groups of people later on.
Key takeaways
- Tests a new adrenaline nose spray for severe allergies.
- Compares nose spray to standard adrenaline injection.
- Checks how safely the medicine affects the body (e.g., heart rate).
- Early-stage study, focused on safety and how medicine works.
- Involves healthy adult volunteers with hay fever.
- Both men and women can participate if they meet health criteria.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part if they meet other health requirements.
Both men and women can join this study. The researchers are looking for people who are generally healthy, though you can have allergic rhinitis (like hay fever or other nasal allergies) – in fact, this is a specific condition mentioned in the study details.
However, if you have other serious health conditions, especially those affecting your heart or other major body systems, you may not be able to participate. The study team will conduct thorough checks to ensure it's safe for you to take part.
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 18 years old or older?
- Do you have allergic rhinitis (like hay fever)?
- Are you generally healthy, without serious long-term health problems?
- Are you comfortable receiving both a nose spray and an injection?
- Are you able to attend study visits as required?
What does participation involve?
If you decide to take part in this study, you will be given both the new adrenaline nose spray (OX640) and the standard adrenaline injection at different times. This is called a 'crossover' study, meaning you will receive both treatments. The study is 'open-label,' which means both you and the study team will know which treatment you are receiving at a particular time.
Throughout your participation, the study team will carefully monitor your body's response. This will likely involve regular check-ups, blood tests, and measurements of your vital signs, such as blood pressure and heart rate, to see how the medication affects you. You will also be asked about any side effects you might experience. The total duration of your participation will be explained by the study team, including the number of visits and follow-up required.
Potential risks and benefits
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Common questions
What is anaphylaxis?
Anaphylaxis is a severe, life-threatening allergic reaction that needs urgent medical attention, often treated with adrenaline.
What is epinephrine?
Epinephrine is another name for adrenaline, a natural chemical in your body and a medicine used to treat severe allergic reactions.
What does 'open-label' mean?
It means both you and the study doctors will know which treatment you are receiving at any given time during the study.
What is 'allergic rhinitis'?
Allergic rhinitis is a common condition often called hay fever, causing sneezing, runny nose, and itchy eyes due to allergies.
Will I get the nose spray instead of the injection?
In this specific study, you will receive both the nose spray and the injection at different times, as part of the comparison.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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