This study calculates the cost reduction of add-on FeNO testing compared to standard diagnostic, to finally support FeNO testing in guidelines.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint:
• (Theoretical) reduction of BPTs
Secondary outcome
Secondary endpoints:
• Direct healthcare costs of diagnosis (avoidable BPTs, extra costs of FeNOs,
extra diagnose costs in FeNO >= 50 ppb and negative BPT)
• The diagnostic burden of FeNO testing and BPT testing (VAS -score and AQLQ)
• Asthma control (ACQ)
Secondary parameters:
- Patient characteristics
- Asthma profile (eosinophils, sIgE to inhalation allergens)
- Lung function (FEV1 and Forced Vital Capacity (FVC) and FVC/ FEV1)
- Outcome BPT (positive/negative)
- FeNO test outcome (ppb)
Background summary
The Global Initiative of Asthma Guideline (GINA) recommends a flowchart to
diagnose asthma with spirometry (with reversibility) and as a second step a
bronchial provocation test (BPT) with histamine or methacholine (1). However,
the BPT is considered as burdensome, not without risk, and expensive (2). In
addition, this time-consuming test strongly encumbers the lung function
capacity.
This is a prospective implementation study investigating a *new diagnostics
work-up* with the Fractional exhaled Nitric Oxide (FeNO) test as an
intermediate step between the spirometry with reversibility and the BPT, with
the aim to determine the impact of the FeNO-based strategy, in terms of
(theoretical) number of avoided BPTs, cost reduction and reduced burden to the
patient. So, this study is intended to demonstrate the added value of the FeNO
test as an *add-on* test incorporated in the diagnostic flow-chart (not a
stand-alone diagnostic tool) for asthma diagnostics and with the ultimate goal
of implementing the FeNO test in the diagnostic algorithm for asthma in the
guidelines. This is also the first study that investigates the cost reduction
of incorporating the FeNO test in the diagnostic flowchart.
Study objective
This study calculates the cost reduction of add-on FeNO testing compared to
standard diagnostic, to finally support FeNO testing in guidelines.
Study design
Prospective implementation study
Intervention
Standard care
• Consult pulmonary physician
• Blood sampling
• Spirometry
• Visual Analogue Scale (VAS) and Asthma Quality of Life Questionnaire (AQLQ)
• Asthma Control Questionnaire (ACQ)
Visit 1
• The patient will be asked for informed consent and to complete a self-made
questionnaire to obtain general information about the patient*s characteristics
before the diagnostic procedure
• FeNO measurement
• BPT
• VAS and AQLQ
Standard care
• ACQ after 3 months of treatment
Study burden and risks
This study has a low burden for the participating patients because the new
diagnostic work-up in this study does not differ much from the standard
diagnostic work-up. Only the FeNO test (which takes 5 minutes), a very simple
and low-burden lung function test is extra. The blood sampling is the same as
in routine diagnostics for asthma. The questionnaires after each diagnostic
test and after 3 months will take 5 minutes extra per questionnaire.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
Inclusion criteria
• Patients >= 18 years, referred by the general practitioner to the outpatient
clinic pulmonology with the suspicion of asthma
• Patients without reversibility at the spirometry (delta FEV1 >= 200 ml and
>=12% improvement)
• Patients understand the Dutch or English language for giving informed consent
and to complete the questionnaires
• They can discontinue their medication (discontinuation time depends on the
kind of medication, paragraph 3.2)
Exclusion criteria
Patients will be excluded if:
• They have a fixed obstruction or with already the diagnose with asthma based
on prior tests
• They are pregnant
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 | NL81129.100.23 |