An observational study in Asthma, sponsored by Copenhagen University Hospital, Hvidovre. Status unknown. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Copenhagen University Hospital, Hvidovre · Observational
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.
Background \& Aim Asthma is the most common chronic disease among children, adolescents and adults. When the diagnosis has been confirmed and the necessary level of treatment established, a well-treated asthma patient is an individual without asthma symptoms. However, asthma is a heterogeneous disease and achieving disease control is far from easy in all asthma patients, although the exact proportion of this problem in real life is unknown. In Denmark, CPR provides the opportunity to track all patients with regard to diagnosis and management, and on a one-by-one basis to merge several informative registers to follow prescribed medication, filled prescriptions, education, area of residence, job, sick leave and referral to secondary care for both asthma and co-morbidities. Based on analysis of data on filled prescriptions from the Danish National Health Service Prescription Database (DNHSPD), it has been demonstrated that only one third of patients classified as having uncontrolled asthma are seen in secondary care.
Based on a nationwide asthma database and clinical confirmation, The Investigators aim to:
Hypotheses \& Expected results
Methods
The initial studies are designed as retrospective, observational studies with a real-world evidence, registrybased design. The study period is 1/6-14 to 31/5-18. Databases used are:
The clinical follow-up (reassessment) study is designed as an interventional, non-randomized, non-blinded clinical study with the aim of assessing the effect of systematic asthma assessment (as suggested by the Nordic Severe Asthma Network) on patients with possible severe asthma not seen by a pulmonologist.
Effects are measured as
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 550 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Copenhagen University Hospital, Hvidovre is the lead sponsor of 76 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Recruitment to the reassessment study is performed through the national Danish Clinical Registries - Asthma-database, which consists of about 200 000 patients. Patients in the database have either 1) had specialist treatment for their asthma or 2) redeemed prescriptions for asthma medications such as inhaled corticosteroids.
The population sought is a representative sample of patients who are receiving high-dosage inhaled corticosteroid treatment for their asthma by their general practitioner.
Active treatment
Exclusion Criteria:
150 invited participants in active treatment with high-dose inhaled corticosteroids plus second controller as per NICE guidelines, without active treatment from a pulmonologist. Intervention includes: 1. Extensive pulmonary and allergy assessments. Questionnaires, FeNO-measurement, Skin prick-test, Spirometry, Blood sampling, Body Plethysmography and Diffusion capacity measurement, Bronchial challenge test, Induced sputum. 2. Treatment optimization As per GINA and Nordic Severe Asthma Network guidelines. Treatment can either be stepped up (e.g. added biological treatment), stepped down or held constant. Treatment is then monitored with regard to symptoms and socioeconomical parameteres such as sick leave over a 12 month period using questionnaires and official databases.
Diagnostic Test: Full pulmonary specialist assessment
400 invited participants in active treatment with high-dose inhaled corticosteroids plus second controller as per NICE guidelines, without active treatment from a pulmonologist. The control cohort is followed for 12 months using questionnaires and official databases with regard to disease control and socioeconomic parameteres such as sick leave.
Please see description for the intervention arm.
Prevalence of severe asthma
The actual prevalence of severe asthma in a cohort of asthma patients treated with high-dose inhalation corticosteroids by a general practitioner.
Time frame: 12 months
Asthma Control Test/Astma Control Questionnaire-scores
Changes in Asthma Control Test/Astma Control Questionnaire-scores over time and after pulmonary specialist reassessment Asthma Control Test is a 5 question questionnaire on asthma disease symptom burden, ranging from 5 to 25, with scores under 20 being indicative of poor disease control, and scores between 20 and 25 indicating some or full disease control. Astma Control Questionnaire is a 7 item questionnaire on asthma diease symptom burden, rescue medication use and lung function. Each item is scored from 0 to 6, with a mean score (total score of all items divided by 7) of 0 to 0.75 suggesting well controlled disease, 0.76-1.5 is a "gray area" and \>1.5 is indicative of poorly controlled disease.
Time frame: 12 months
SABA/SAMA usage
Change in redemption of short-acting bronchodilator prescriptions as a surrogate for increased disease control
Time frame: 12 months
Exposure to systemic corticosteroids
Change in redemption of systemic corticosteroid prescriptions as a surrogate for increased disease control.
Time frame: 12 months
Acute exacerbations
Change in number of exacerbations requiring systemic corticosteroids or hospitalization.
Time frame: 12 months.
No study locations are listed for this record.
Plan to share: Undecided — Data sharing upon reasonable request, however, approval from Statistics Denmark and the National Prescription Database might be required.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital, Hvidovre