AsthmaREASSESSNCT04193150
Uncontrolled and Possible Severe Asthma in Denmark
An observational study of Asthma, run by Copenhagen University Hospital, Hvidovre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Asthma
- What is being tested?
- Full pulmonary specialist assessment
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Uncontrolled and Possible Severe Asthma in Denmark - What is the Magnitude of the Problem?
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.
Read the detailed description
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:
- Describe the patient demographics and disease-burden in patients with possible hidden severe asthma in Denmark, using the national databases.
- Elucidate the real-world prevalence of hidden severe asthma in Denmark, by systematic assessment of patients with possible hidden severe asthma.
- Investigate the impact of systematic asthma assessment on quality of life and asthma control in patients with possible hidden severe asthma.
Hypotheses \& Expected results
- Within the last year, a large proportion of asthma patients (75%) prescribed medium to high doses of inhaled corticosteroids (ICS) have not had their lung function measured, had no new asthma drugs prescribed and have not been referred to secondary care for further assessments.
- A significant number of asthma patients in primary care are prescribed high doses of ICS and filled prescriptions for >200 puffs of rescue medication (short-acting beta 2-agonists (SABA) or anticholinergics (SAMA)) per year over a period of 2 years, exhibiting low disease awareness of the difficult to manage asthma patients by both doctors and patients.
- In primary care, more than 75% of asthma patients prescribed high dose ICS and a second controller have been seen in secondary care within the last year, leaving few (25%) with possible hidden severe asthma in primary care.
- In primary care, there is a significant mismatch between general practitioner (GP)-based diagnosis of severe asthma (based on prescription data) and the true prevalence of severe asthma following guideline-based systematic assessment for severe asthma.
- A systematic pulmonary assessment in patients with possible severe asthma leaves few with a severe asthma diagnosis and increases disease control in patients with moderate-to-mild asthma. A significant proportion of patients are able to step-down in inhaled steroid treatment as described in GINA guidelines.
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:
- Danish Clinical Registries (DCR) - Asthma
- National Patient Registry (NPR) \& Statistics Denmark (DST)
- The Danish National Health Service Prescription Database (DNHSPD)
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
- improvements of symptoms and quality of life according to questionnaires and
- improvements of clinical variables such as lower peak expiratory flow (PEF) variability.
- Conditions
- Asthma
- Being tested
- Full pulmonary specialist assessment
- Keywords
- disease control, socioeconomics, difficult-to-treat
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full pulmonary specialist assessmentDiagnostic test
Please see description for the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
SABA/SAMA usage
Change in redemption of short-acting bronchodilator prescriptions as a surrogate for increased disease control
Measured: 12 months
Exposure to systemic corticosteroids
Change in redemption of systemic corticosteroid prescriptions as a surrogate for increased disease control.
Measured: 12 months
Acute exacerbations
Change in number of exacerbations requiring systemic corticosteroids or hospitalization.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study startOct 2022 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kjell Håkansson, Copenhagen University Hospital, Hvidovre
- Investigators
- Charlotte Suppli Ulrik, Professor, Study chair, csulrik@dadlnet.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193150
- Sponsor's protocol ID
- HVH237-KEJH-REASSESS
- Acronym
- REASSESS
- Status last verified
- Jul 2022
- First submitted
- 4 Dec 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing upon reasonable request, however, approval from Statistics Denmark and the National Prescription Database might be required.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled and Possible Severe Asthma in Denmark - What is the Magnitude of the Problem?
- ClinicalTrials.gov ID
- NCT04193150
- Acronym / sponsor ID
- REASSESS / HVH237-KEJH-REASSESS
- Conditions
- Asthma
- Keywords
- disease control, socioeconomics, difficult-to-treat
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Describe the patient demographics and disease-burden in patients with possible hidden severe asthma in Denmark, using the national databases.
- Elucidate the real-world prevalence of hidden severe asthma in Denmark, by systematic assessment of patients with possible hidden severe asthma.
- Investigate the impact of systematic asthma assessment on quality of life and asthma control in patients with possible hidden severe asthma.
Hypotheses \& Expected results
- Within the last year, a large proportion of asthma patients (75%) prescribed medium to high doses of inhaled corticosteroids (ICS) have not had their lung function measured, had no new asthma drugs prescribed and have not been referred to secondary care for further assessments.
- A significant number of asthma patients in primary care are prescribed high doses of ICS and filled prescriptions for >200 puffs of rescue medication (short-acting beta 2-agonists (SABA) or anticholinergics (SAMA)) per year over a period of 2 years, exhibiting low disease awareness of the difficult to manage asthma patients by both doctors and patients.
- In primary care, more than 75% of asthma patients prescribed high dose ICS and a second controller have been seen in secondary care within the last year, leaving few (25%) with possible hidden severe asthma in primary care.
- In primary care, there is a significant mismatch between general practitioner (GP)-based diagnosis of severe asthma (based on prescription data) and the true prevalence of severe asthma following guideline-based systematic assessment for severe asthma.
- A systematic pulmonary assessment in patients with possible severe asthma leaves few with a severe asthma diagnosis and increases disease control in patients with moderate-to-mild asthma. A significant proportion of patients are able to step-down in inhaled steroid treatment as described in GINA guidelines.
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:
- Danish Clinical Registries (DCR) - Asthma
- National Patient Registry (NPR) \& Statistics Denmark (DST)
- The Danish National Health Service Prescription Database (DNHSPD)
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
- improvements of symptoms and quality of life according to questionnaires and
- improvements of clinical variables such as lower peak expiratory flow (PEF) variability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reassessment Cohort | – | Diagnostic Test: Full pulmonary specialist assessment150 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. |
| 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age 18-74 at the time of signing the informed consent form.
- Physician diagnosed asthma.
- Active treatment
- No asthma-related contact to a respiratory medicine outpatient clinic during the last 36 months.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full pulmonary specialist assessmentPlease see description for the intervention arm. | Diagnostic test | Reassessment Cohort |
Primary outcome
Prevalence of severe asthma
Time frame: 12 months
The actual prevalence of severe asthma in a cohort of asthma patients treated with high-dose inhalation corticosteroids by a general practitioner.
4 secondary outcomes
Asthma Control Test/Astma Control Questionnaire-scores
Time frame: 12 months
SABA/SAMA usage
Time frame: 12 months
Exposure to systemic corticosteroids
Time frame: 12 months
Acute exacerbations
Time frame: 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: Undecided. Data sharing upon reasonable request, however, approval from Statistics Denmark and the National Prescription Database might be required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Suppli Ulrik, Professor study chair
csulrik@dadlnet.dk
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Copenhagen University Hospital, Hvidovre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alma Holm Rovsing, MD (004538623825, alma.holm.rovsing@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of severe asthma (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.