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 reactio
Phase 1
- Conditions
- Acute allergic reactionMedDRA version: 20.1Level: LLTClassification code: 10000656Term: Acute allergic reaction Class: 10021428Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-504975-25-00
- Lead Sponsor
- AcuCort AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Male or female patients = 18 years of age, willing and able to give written informed consent for participating in the trial who previously have experienced acute allergic reactions and who is currently prescribed betamethasone tablets for treatment of such reactions.
Exclusion Criteria
Patient who cannot handle a web-based eDiary via their own electronic device (phone, tablet)., Patients with other medical conditions that in the opinion of the Investigator would exclude the patient from trial participation., Patients who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the patient’s overall satisfaction with having access to Zeqmelit™ 6 mg in relation to the patient’s standard treatment overall, and in case of an acute allergic reaction.;Secondary Objective: To evaluate the patient’s user experience of Zeqmelit™ 6 mg mouth film in case of an acute allergic reaction., To evaluate the patient’s perceived effectiveness of Zeqmelit™ 6 mg mouth film in case of an acute allergic reaction.;Primary end point(s): Overall satisfaction in terms of general satisfaction and feeling safe. (Questions: 1f/4h, 2i, 3a-d, 4a-g).
- Secondary Outcome Measures
Name Time Method Secondary end point(s):User experience in terms of choice of treatment, having access to treatment and other medication. (Questions: 2a-g, 2j-n, 3e-g).;Secondary end point(s):Perceived effectiveness of Zeqmelit™ 6 mg mouth film. (Question: 2h).