The main objective of this study is to observe current AE treatment strategies and the treatment response of these strategies after 2 weeks in several hospitals. Secondary objectives are (1) to measure effect treatment on FeNO, eosinophils and…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are (1) the chosen treatment strategy (e.g.
cumulative dose of prednisone and/or antibiotics), and (2) treatment
effect measured on day 14. Treatment effect is determined on the need of
additional AE treatments between day 0 and 14. Treatment effect is also
measured by the physician and patient rated global evaluation of treatment
effectiveness (GETE) score, difference in Asthma Control Questionnaire 5
(ACQ-5), difference in forced expiratory volume (FEV1) measured with handheld
spirometry.
Secondary outcome
Secundary study parameters are (1) to measure effect treatment on FeNO,
eosinophils an neutrophils (at day 0 and day 14), (2) to monitor the side
effects of prednisone, (3) to measure asthma control and stress and emotional
wellbeing (questionnaire) and its possible correlation with the (patient
experienced) treatment effect, and (4) to observe the chance on AAE relapse
within 6 weeks.
Background summary
Asthma is a heterogeneous inflammatory airway disease affecting 8-9% of the
European population and is the most common chronic disease among children.
Moderate-to-severe asthma exacerbations (AE) are treated with bronchodilators,
oral corticosteroids (OCS) and/or antibiotics, with little attention paid to
the underlying asthma heterogeneity in type of inflammation and exacerbation
triggers. Although precision medicine and targeted therapies, such as
biologicals, are practiced in the maintenance treatment of severe asthma, this
does not (yet) apply to AE management. For AE treatment to move forward, tools
are urgently needed to more accurately phenotype and classify AE. An improved
understanding of inflammatory pathways, identification of a rapid
discriminative marker set, and exploration of precision medicine strategies are
crucial for ensuring appropriate use of anti-inflammatory drugs and antibiotics
in a personalized fashion. This is expected to improve clinical outcomes and
reduce adverse events and costs.
Study objective
The main objective of this study is to observe current AE treatment strategies
and the treatment response of these strategies after 2 weeks in several
hospitals. Secondary objectives are (1) to measure effect treatment on FeNO,
eosinophils and neutrophils (at day 0 and day 14), (2) to monitor the side
effects of prednisone, (3) to measure stress and emotional wellbeing
(questionnaire) and its possible correlation with the (patient experienced)
treatment effect, and (4) to observe the chance on AE relapse within 6 weeks.
Study design
The study is a multicenter prospective study and consist of 2 phases. In the
1st phase, we will perform an observational cohort study in regional hospitals.
This cohort also serves as a *control* cohort in the phase 2 stepped wedge
cluster-randomized trial investigating the overall performance of the AE
treatment algorithm on clinical outcomes and medication use in AE. For phase 2
separate METC approval will be requested.
Study burden and risks
Participating patients will not have personal benefit from participating in
this study. The low burden from participating in this study is proportional
with the potential value for the total asthma population. The low burden for
patients includes venous puncture (on day 0 and day 14), questionnaires (on day
0,, day 7, day 14 and day 42), spirometry and FeNO measurements (on day 0 and
day 14).
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
Inclusion criteria
Adult (16+) patient diagnosed with asthma according to the GINA guidelines.
Moderate 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 informed consent, prior to any study procedures.
Eligibility and willingness to present during an asthma exacerbation at the
outpatient clinic facility of the study sites.
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) biologicals used for
the treatment of asthma.
Other underlying inflammatory or auto-immune diseases, 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.
Already started with systemic corticosteroids course before possible inclusion.
Design
Recruitment
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 | NL87351.100.24 |