The primary objective of the study is to determine the relationship between exacerbation treatment response at day 7 and the phenotypical characteristics of asthma exacerbations. Secondary objectives are 1) developing a prediction model based on…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the relation of phenotypical characteristics with treatment
response at day 7, defined by 1) the physician - and patient rated global
evaluation of treatment effectiveness (GETE) score 2) difference in Asthma
Control Questionnaire 5 (ACQ-5) (> 0.5) 3) difference in handheld spirometry
values like forced expiratory volume (FEV1 >= 10%). Treatment response will be
classified as excellent, good, moderate or poor.
Secondary outcome
Secondary endpoints are 1) a prediction model for the treatment response of AAE
2) aetiology of the AAEs 3) blood and local respiratory parameters; microbiota
composition; lipid metabolomics and volatile compounds composition at baseline
and AAE
Background summary
Asthma is a heterogeneous inflammatory respiratory disease affecting 8 - 9% of
the European population. Acute asthma exacerbation (AAE) is characterized as an
acute worsening of symptoms and is treated inconsistently with steroids with or
without antibiotics. In order to adjust and personalise exacerbation treatment,
phenotyping and classifying of asthma exacerbations would be required.
Therefore, we want to classify patients with AAEs phenotypically in relation to
the treatment response.
Study objective
The primary objective of the study is to determine the relationship between
exacerbation treatment response at day 7 and the phenotypical characteristics
of asthma exacerbations.
Secondary objectives are 1) developing a prediction model based on biomarkers
and/or clinical data to predict the treatment response of AAEs 2) comparing the
environmental, inflammatory, microbiological and lipid parameters of patients
diagnosed with asthma between exacerbation phase and recovery (baseline)
Study design
A prospective cohort multicenter study.
Study burden and risks
Asthma patients will not have personal benefit from participating in this
study. The low burden from participating in this study is in proportion with
the potential value of this study for the total asthma population. The low
burden for patients includes the venous punctures (2x), nasopharyngeal swabs
(2x), performing daily questionnaires, spirometry, and FeNO measurements for a
week.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
Inclusion criteria
- Patients between 12 and 70 years old, diagnosed with asthma according to the
GINA guidelines. If patients are doctor*s diagnosed with asthma based on
clinical data, the further diagnostics will be performed to confirm the
diagnosis after the AAE.
- Mild to severe asthma, treated according to GINA guidelines with medium - or
high dose inhaled corticosteroids (with or without LABA) or treated with a low
dose inhaled corticosteroids combined LABA or leukotriene - receptor
antagonist.
- Asthma exacerbation, indication for systemic corticosteroids.
- Written personal and/or parental informed consent, prior to any study
procedures.
- Eligibility and willingness to present during an asthma exacerbation at the
outpatient clinic of the Study sites.
- Ability to use e - health applications.
Exclusion criteria
- Immunosuppressive maintenance medication (azithromycin, systemic
corticosteroids maintenance therapy and other) or recently (< 6 weeks)
discontinued these medications. (Desensitization therapy indicated for
allergies can be included in the study)
- Maintenance medication or recently discontinued (< 6 weeks) anti-inflammatory
biologicals.
- Other underlying active inflammatory or auto-immune diseases with systemic
immunosuppressive medication, such as rheumatologic disease.
- Involvement in the planning and/or conduct of the study (applies to both
investigator staff and/or staff at the study site)
- Pregnancy, because of the possible altered immunological status.
- Participation in an interventional study or randomised controlled trial.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79257.100.21 |