Uncontrolled and Possible Severe Asthma in Denmark (NCT04193150) | Clinical Trial Compass
UnknownNot Applicable
Uncontrolled and Possible Severe Asthma in Denmark
550 participantsStarted 2022-10
Plain-language summary
Asthma is a common, chronic disease with a high prevalence in children, adolescents and populations normally fit-to-work. Most asthma patients have a well-controlled disease and thereof a low usage of primary and secondary health care, as well as few sick days. With difficult-to-treat and severe asthma, a much higher health care and sick leave resource usage is seen. Previous studies show that only 1/3rd of patients prescribed high-dose, possibly side effect-laden, medications for difficult-to-treat or possible severe asthma have been seen by a specialist, such as a pulmonologist.
Our study aims to identify socioeconomical patterns and describe patients who are in high dosage asthma treatments, without being seen or treated by a specialist. Furthermore, The Investigators wish to investigate the impact of a systematic pulmonary assessment on quality of life, healthcare utilization and social benefit usage in patients with possible severe asthma.
The results are meant to provide a dataset to identify weaknesses in asthma treatment on a national level, and to lay a foundation for future quality improvements to asthma care in Denmark.
Who can participate
Age range
18 Years – 74 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
. Age 18-74 at the time of signing the informed consent form.
. Physician diagnosed asthma.
. Active treatment
. Defined as minimum 1 filled prescription of an obstructive pulmonary disease drug (ACT R03) during the last 12 months.
. Dosage of ICS as described in the NICE guidelines.
. No asthma-related contact to a respiratory medicine outpatient clinic during the last 36 months.
Exclusion criteria
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.
. Inability to participate in questionnaires during the 12 months follow-up. Note: follow-up questionnaires can be provided in printed form, should the patient not have internet access.
. Inability to participate in baseline spirometry, blood sampling and skin prick test.
. Inability to abstain from pre-assessment meals and caffeine (2 hours), smoking (same day), ICS (1 day) and bronchodilators (24 hours).
. Any clinically important concomitant severe pulmonary disease such as COPD without an asthmatic/significant reversible component, pulmonary fibrosis, cystic fibrosis, lung cancer, previous lobectomy, alpha 1 anti-trypsin deficiency, primary ciliary dyskinesia, allergic aspergillosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome.