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 range18 Years – 74 Years
SexALL
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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
✕. Inability to give informed consent.
✕. 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.