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Study on Dexamethasone Film for Patients with Acute Allergic Reactions

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of acute allergic reactions. The treatment being evaluated is a medication called Zeqmelit™ 6 mg, which comes in the form of a mouth-dissolving film. This film contains the active ingredient dexamethasone, a type of medication commonly used to reduce inflammation and suppress the immune system's response during allergic reactions.

The purpose of the study is to assess how satisfied patients are with using Zeqmelit™ compared to their usual treatment, especially during an acute allergic reaction. Participants in the study will use the mouth-dissolving film and provide feedback on their overall satisfaction, including how safe they feel using it. The study will also gather information on the participants' experiences with the treatment, such as their choice of treatment and access to it, as well as their perception of its effectiveness.

Throughout the study, participants will be asked to answer questions about their satisfaction and experiences with the treatment. This will help researchers understand how Zeqmelit™ compares to standard treatments for acute allergic reactions. The study is designed to be low-intervention, meaning it aims to minimize any disruption to the participants' usual treatment routines.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be asked to provide written informed consent. This means you agree to participate and understand the details of the study.

    You must be at least 18 years old and have experienced acute allergic reactions in the past. You should currently be prescribed betamethasone tablets for these reactions.

  2. Step 2

    Receiving the medication

    You will receive a medication called Zeqmelit™ 6 mg, which is a mouth-dissolving film. This is used to treat acute allergic reactions.

    The film is designed to dissolve in your mouth, making it easy to take without water.

  3. Step 3

    Using the medication

    You will use the Zeqmelit™ 6 mg film as needed when you experience an acute allergic reaction.

    Follow the instructions provided by the study team regarding the dosage and frequency of use.

  4. Step 4

    Providing feedback

    Throughout the trial, you will be asked to provide feedback on your experience using the Zeqmelit™ 6 mg film.

    This feedback will include your overall satisfaction, feelings of safety, and perceived effectiveness of the medication.

  5. Step 5

    End of trial

    The trial is expected to end by July 1, 2024.

    At the end of the trial, your feedback will help evaluate the user experience of the Zeqmelit™ 6 mg film.

Who can join the trial?

5 criteria

  • Patients must be 18 years of age or older.
  • Patients can be male or female.
  • Patients must be willing and able to give written informed consent. This means they agree to participate in the study and understand what it involves.
  • Patients must have previously experienced acute allergic reactions. An acute allergic reaction is a sudden and severe allergic response.
  • Patients must be currently prescribed betamethasone tablets for treating their allergic reactions. Betamethasone is a type of medication used to reduce inflammation and allergic responses.

Who cannot join the trial?

1 criterion

  • Patients who have an acute allergic reaction cannot participate. An acute allergic reaction is a sudden and severe allergic response that can cause symptoms like swelling, difficulty breathing, or a rash.
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Investigated drugs

Zeqmelit™ is a medication used in this clinical trial to help people who have sudden allergic reactions. It comes in a form that dissolves in your mouth, making it easy to take without needing water. The goal of using this medication in the trial is to see how satisfied patients are with it compared to their usual allergy treatments. This medication is designed to work quickly to relieve symptoms like itching, swelling, and difficulty breathing that can happen during an allergic reaction.

What is already known about the treatment

Zeqmelit™ – Zeqmelit™ is a medication administered as a 6 mg mouth dissolving film, designed for easy use during acute allergic reactions. It is currently being evaluated in a phase IV clinical trial to assess user satisfaction compared to standard treatments for such reactions. The main therapeutic indication for Zeqmelit™ is to provide relief during sudden allergic responses. At the molecular level, it works by blocking certain chemicals in the body that cause allergy symptoms. Zeqmelit™ falls under the pharmacological classification of antihistamines, which are commonly used to treat allergic conditions.

Investigated diseases

Acute allergic reaction – An acute allergic reaction occurs when the immune system responds aggressively to a foreign substance, known as an allergen. This reaction can happen quickly, often within minutes to a few hours after exposure to the allergen. Symptoms may include hives, itching, swelling, difficulty breathing, and gastrointestinal discomfort. The severity of symptoms can vary, ranging from mild irritation to more severe manifestations like anaphylaxis. Anaphylaxis is a serious condition that can cause a sudden drop in blood pressure and narrowing of the airways, requiring immediate attention. The progression of an acute allergic reaction can be rapid, necessitating prompt recognition and management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504975-25-00Protocol codeZEQ-001Estimated enrolment50 patientsSponsorAcuCort AB

sourced from the EU Clinical Trials Register and site verification

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