Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

A phase IV, open, non-randomised, low-intervention clinical trial to evaluate the subjective user experience of Zeqmelit™ 6 mg mouth dissolving film for treatment of acute allergic reaction

This study is looking into how people experience using a new medicine called Zeqmelit™ 6 mg mouth film for sudden allergic reactions. It's designed to be a simple, 'real-world' study where everyone involved knows they are taking the Zeqmelit film. The main goal is to understand how satisfied people are with this treatment, focusing on their general happiness with it and whether they feel safe using it. We also want to find out what people think about how well it works, how easy it is to get, and if they prefer it over other treatments. This information will help doctors understand if this medicine is a good choice for people with acute allergic reactions.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

AcuCort AB

Enrolment target

Start

14 Jun 2023

Acute allergic reaction

What is this study about?

Imagine you have a sudden, unexpected allergic reaction. It can be quite scary, and you need something that works quickly and is easy to use. This study is all about a new treatment called Zeqmelit™ 6 mg mouth film, which is designed to help with these acute allergic reactions.

This isn't a study where some people get the medicine and others get a dummy treatment. Everyone in this study will be trying the Zeqmelit™ mouth film. We want to get your honest opinion about your experience. Researchers are especially interested in whether you feel happy and safe when using this film. We're looking at things like how easy it is to take, if you feel it works well for you, and how it fits into your life regarding your other medications.

By gathering this information, we hope to learn more about how Zeqmelit™ mouth film works for real people with acute allergic reactions. This feedback is really important because it helps doctors and healthcare providers understand if this medication is a good, user-friendly option for people who need to manage their allergies quickly and effectively.

Key takeaways

This study is about a new mouth-dissolving film for sudden allergic reactions.
It aims to see how satisfied and safe people feel using the new treatment.
Only adults (18+) can join, both men and women.
Participation involves using the film if needed and completing questionnaires.
Your feedback helps improve future allergy care.
You can stop participating at any time.

Who may be eligible?

This study is looking for volunteers who are adults, meaning you need to be 18 years old or older. There is no upper age limit, so people of all adult ages are welcome to take part.

Both men and women can join this study. The researchers are interested in hearing from everyone who experiences acute allergic reactions, regardless of their gender.

While the main requirements are being over 18 and experiencing acute allergic reactions, the study team will ask you a few more questions to make sure it's the right study for you. This is to ensure your safety and that the study results are accurate.

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 experience acute allergic reactions?
Are you willing to use a new mouth-dissolving film if needed?
Are you able to answer questions about your experience with medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need to visit a special clinic repeatedly. Instead, it's designed to look at your real-life experience with Zeqmelit™ 6 mg mouth film. You will be given the medication and asked to use it if you have an acute allergic reaction. After using it, you'll be asked to complete some questionnaires. These questions will be about how you felt about the medicine, how easy it was to use, and if you think it helped you. The study will continue for a certain period, and you'll complete questionnaires at specific times during that period. The total duration of your involvement will be explained to you in detail by the study team, but it focuses on your experience after using the film.

Potential risks and benefits

Taking part in this study may offer the benefit of trying a new and potentially easy-to-use treatment for acute allergic reactions. Your feedback will also help improve care for others. As with any medication, there's always a chance of side effects, but Zeqmelit™ is already a licensed medication, meaning it has been through previous safety checks. The study team will explain any known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is an acute allergic reaction?

It's a sudden, strong allergic response to something like food, insect stings, or medication, which can cause symptoms like skin rashes, swelling, or breathing difficulties.

What is Zeqmelit™ 6 mg mouth film?

It's a new form of medication designed to dissolve quickly in your mouth to treat sudden allergic reactions.

Do I have to take this medicine if I join the study?

You will be given the medicine to use if you experience an acute allergic reaction during the study period. You are not forced to take it if you don't need it or choose not to.

Will I know if I'm getting the active medicine?

Yes, this is an 'open' study, meaning everyone who takes part will receive the Zeqmelit™ 6 mg mouth film if they need a treatment during the study.

How long will I be involved in the study?

The study team will tell you the exact time commitment, but it usually involves completing surveys about your experience after using the medication for a set period.