The main objective is to investigate the heterogeneity of type 2 asthma by identifying phenotypes by means of cluster analysis. Secondary, the clinical interpretation of these clusters is investigated.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
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.
Study objective
The main objective is to investigate the heterogeneity of type 2 asthma by
identifying phenotypes by means of cluster analysis. Secondary, the clinical
interpretation of these clusters is investigated.
Study design
The study will have an observational cross-sectional design. 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 burden and risks
The risk for adverse events due to participation in this study is minimal.
Subjects will undergo measurements according to the standard protocols as used
in daily clinical care. There is no direct benefit for patients. However, it
might result in more personalized medicine and improved prognosis for asthma
patients.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77049.100.21 |
| OMON | NL-OMON24616 |