Phenotyping and Classifying Asthma Exacerbations (NCT05304039) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Phenotyping and Classifying Asthma Exacerbations
Netherlands200 participantsStarted 2022-09-28
Plain-language summary
An observational study in patients between 12 and 70 years old with an acute asthma exacerbation, to determine the relation between phenotypical characteristics and the treatment response.
Who can participate
Age range
12 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient diagnosed with asthma according to the GINA guidelines between 12 and 70 years old. If patients are doctor's diagnosed with asthma based on clinical data, the further diagnostics will be performed to confirm the asthma diagnosis after the AAE.
* Mild to severe asthma, treated according to GINA guidelines with medium - or high dose inhaled corticosteroids (with or without LABA) or treated with a low dose inhaled corticosteroids combined LABA or leukotriene - receptor antagonist.
* Asthma exacerbation, indicated for systemic corticosteroids.
* Written personal and/or parental informed consent, prior to any study procedures.
* Eligibility and willingness to present during an asthma exacerbation at the Franciscus Gasthuis hospital.
* Ability to use e - health applications.
Exclusion Criteria:
* Immunosuppressive maintenance medication (azithromycin, systemic corticosteroids maintenance therapy and other) or recently (\< 6 weeks) discontinued these medications. (Desensitization therapy indicated for allergies can be included in the study)
* Maintenance medication or recently discontinued (\< 6 weeks) biologicals.
* Other underlying inflammatory or auto-immune diseases, such as rheumatologic disease.
* Involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site)
* Pregnancy, because of the possible altered immunological status.(31)
* Participation in an interventional study or randomised…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relation of phenotypical characteristics with treatment response