Uncontrolled and Possible Severe Asthma in Denmark

NCT04193150 | Unknown DMC

• 1 other identifier: HVH237-KEJH-REASSESS
• Study Type: observational
• Target: 550
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma

Keywords

disease control; socioeconomics; difficult-to-treat

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (4)

• Asthma Control Test/Astma Control Questionnaire-scores

  12 months

• SABA/SAMA usage

  12 months

• Exposure to systemic corticosteroids

  12 months

• Acute exacerbations

  12 months.

Study Arms (2)

Reassessment Cohort

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

Control Cohort

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.

Interventions

Full pulmonary specialist assessment DIAGNOSTIC_TEST

Please see description for the intervention arm.

Reassessment Cohort

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Biospecimen

Retention: SAMPLES WITH DNA

Induced sputum, Blood samples. Saved in local biobank for future biomarker analysis.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Charlotte Suppli Ulrik, Professor

  csulrik@dadlnet.dk

  STUDY CHAIR

Central Study Contacts

Alma Holm Rovsing, MD

CONTACT

004538623825; alma.holm.rovsing@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 26, 2022

Record last verified: 2022-07