To investigate the fluctuation patterns of different pulmonary parameters in patients with severe asthma, before and after starting a treatment with biologics, using daily measurements with the Respicorder device.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Respicorder device measures standard spirometry (FEV1, FVC), IOS parameters
and FeNO, which will be used for fluctuation analysis. The Asthma Control
Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) will be
used to quantify asthma status. Patients will be evaluated by their treating
clinician after 4 and 6 months of treatment with a biological. The outcome will
be linked to the fluctuation patterns, such that can be evaluated whether these
patterns can be used to predict a successful treatment with a biologic.
Secondary outcome
Spirometry, IOS and FeNO measurements with standard devices as done in standard
care in the hospital will be used to compare with the Respicorder measurements.
Subjects will also be asked about their experience with the Respicorder.
Background summary
Treatment of patients with severe asthma has taken a new avenue with the
introduction of biologics. Currently, treatment success with biologics may be
around 75% and is determined by assessing various biomarkers after 4 to 6
months of treatment. At a stable state, biological processes dynamically
fluctuate within certain borders, which differ between asthma and healthy
controls. By exposure to the common cold virus, we have shown that
destabilizing the condition of asthma patients and healthy controls directly
but temporarily changes the fluctuation patterns of biological processes. We
propose that treatment success also changes fluctuation patterns, and that this
occurs relatively fast after treatment is started. By daily measurements of
spirometry, fraction of exhaled nitric oxide (FeNO) and impulse oscillometry
(IOS), using the Respicorder device, we expect to determine the effect of
treatment at an early stage and limit prolonged treatment of patients with a
non-effective biologic, and the very high costs of these biologics.
Study objective
To investigate the fluctuation patterns of different pulmonary parameters in
patients with severe asthma, before and after starting a treatment with
biologics, using daily measurements with the Respicorder device.
Study design
The study design is an observational cohort study that will include patients
that are scheduled for an intervention with biologic treatment in standard
care. Patients will receive their standard treatment and will perform some
extra measurements during their regular visits and they will perform
measurements with the Respicorder device twice a day at home.
Study burden and risks
The risk for adverse events due to participation in this study is minimal. The
daily additional measurements with the Respicorder device can be a burden to
patients. The Respicorder measurements take about 5 minutes, which we consider
as an acceptable burden given the expected impact of the study. Subjects will
also be subjected to measurements according to the standard protocol in
clinical care.
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Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
• Severe asthma based on the definition by the 2022 GINA guidelines.
• Will start treatment with a biological
• 18-60 years old
• Subject should be willing and able to perform the lung function tests and
other study-related procedures and comply with study protocol requirements.
• Apart from their asthma, subjects should be generally healthy with no history
of a clinically relevant medical condition that in the opinion of the
investigator might interfere with successful study conduct and no clinically
relevant abnormalities on medical history.
• Subjects should provide a signed and dated informed consent
Exclusion criteria
• Has been tested positively for COVID-19 in the past month or has not fully
recovered from an earlier COVID-19 infection (e.g. post-covid syndrome) • Has
been treated with oral corticosteroids as high-dose therapy in the 6 weeks
before visit 1. • Has been treated with another biologic within 3 months before
start treatment with new biological (e.g. 2 months before the start of the
study participation) • Not able to perform spirometry/IOS/FeNO tests correctly
• Not able to handle Respicorder well • Subject is a current smoker/vaper, uses
recreational drugs, or has >10 packyears • Subject is anticipated not to comply
with study protocol or other aspects of the study (at the discretion of the
investigator) • Participation to the study is not medically responsible
according to the study physician and/or principle investigator • Inability to
read and/or understand the Dutch language
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 |
|---|---|
| ClinicalTrials.gov | NCT06024707 |
| CCMO | NL83718.018.23 |