No registrations found.
ID
Source
Brief title
Health condition
Asthma
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the formation of type 2 asthma clusters based on patient and asthma characteristics.
Secondary outcome
Secondary, the found clusters will be compared and clinically interpreted.
Background summary
Asthma is a common heterogeneous disease characterised by bronchial hyperresponsiveness, airway inflammation and reversible airflow obstruction. The clinical, biological and functional characteristics vary widely between patients.
Type 2 inflammation is reflected by high sputum and/or blood eosinophil levels, an increased fractional of exhaled nitric oxide, and/or allergen mediated asthma. These characteristics are especially under attention since they appear to have predictive value for severe exacerbation and for response to biological treatment. Around 75 percent of difficult to treat asthma patients have at least one of these type 2 asthma characteristics.
Disentangling type 2 asthma by defining phenotypes might result in further optimizing patient tailored treatment and improving quality of life.
The main objective is to investigate the heterogeneity of type 2 asthma by identifying phenotypes by means of cluster analysis.
Asthma patients with at least one type 2 asthma characteristic that are under treatment in secondary care will be included. Parameters from demographic data, blood tests, lung function and questionnaires will be used to determine clusters. After assessing the quality and stability of the clusters, they will be compared for clinical interpretation.
Study objective
Several phenotypes can be defined within type 2 asthma
Study design
One
Inclusion criteria
Age ≥18 year (Adult)
Confirmed asthma diagnosis by a health professional
Under treatment in secondary care for asthma
Using ICS on daily basis
At least one type 2 asthma characteristic present:
- High blood eosinophils
- High sputum eosinophils
- High fractional exhaled nitric oxide (FeNO)
- Allergen mediated asthma (allergic symptoms supported by at least one positive specific blood IgE test)
Exclusion criteria
Use of biologicals or prednisolone
Asthma exacerbation within 6 weeks before inclusion
Not able to perform lung function test or having a contraindication to do so
Current smoker or more than 10 pack-years
Has been tested positively for COVID-19 within last two months
Other respiratory diseases than asthma
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9565 |
| CCMO | NL77049.100.21 |
| OMON | NL-OMON51135 |