Clinical trial NCT06230458: Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma
Official title: Care Evaluation Study of the Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diagnosis
Asthma
Keywords: Asthma
Diagnostics
FeNO
Bronchial provocation test
Burdesome
cost-effectiveness
Lead sponsor: Franciscus Gasthuis & Vlietland (Hospital)
Sponsor class: OTHER
Collaborators: name: OLVG
First posted: 2024-01-30
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Global Initiative of Asthma Guideline (GINA) recommends a flowchart to diagnose asthma with first-step spirometry with reversibility and a bronchial challenge test (BPT) with histamine or methacholine as a second step.

This multi-center prospective care evaluation study compares the 'standard asthma diagnostic work-up' (spirometry with reversibility and BPT) to the 'new asthma diagnostics work-up' (FeNO-test as an intermediate step between the spirometry with reversibility and the BPT), intending to determine the impact of the FeNO-based strategy, in terms of the number of avoided BPTs, cost-effectiveness and reduced burden to the patient and health care.

The cost reduction of incorporating the FeNO-test in the new diagnostic algorithm will be established by the number of theoretically avoided BPT. The decrease in burden will be studied by calculating differences in the Visual Analogue Scale (VAS) -score and Asthma Quality of Life Questionnaire (AQLQ) -score after the BPT and FeNO-test with an independent T-test. The accuracy of the FeNO-test will be calculated by comparing the FeNO-test outcomes to the (gold standard) BPTs outcomes in terms of sensitivity and specificity.

Detailed description: Background Asthma is a common disease characterized by chronic inflammation of the lower airways, bronchial hyperactivity, and (reversible) airway obstruction. The Global Initiative of Asthma Guideline (GINA) recommends a flowchart to diagnose asthma with first-step spirometry with reversibility and a bronchial challenge test (BPT) with histamine or methacholine as a second step. The BPT is considered burdensome, time-consuming for patients and staff, can cause side effects, and is expensive. In addition, this test strongly encumbers lung function capacity. Elevated Nitric Oxide (NO) is associated with airway eosinophilic inflammation in asthma patients and can be measured in exhaled air with the Fractional exhaled (Fe) NO-test. This low-burden FeNO-test could be used as an 'add-on' test in asthma diagnostics.

Methods/analysis This multi-center prospective care evaluation study compares the 'standard asthma diagnostic work-up' (spirometry with reversibility and BPT) to the 'new asthma diagnostics work-up' (FeNO-test as an intermediate step between the spirometry with reversibility and the BPT), intending to determine the impact of the FeNO-based strategy, in terms of the number of avoided BPTs, cost-effectiveness and reduced burden to the patient and health care. The accuracy of the FeNO-test is included for verification.

The cost reduction of incorporating the FeNO-test in the new diagnostic algorithm will be established by the number of theoretically avoided BPT. The decrease in burden will be studied by calculating differences in the Visual Analogue Scale (VAS) -score and Asthma Quality of Life Questionnaire (AQLQ) -score after the BPT and FeNO-test with an independent T-test. The accuracy of the FeNO-test will be calculated by comparing the FeNO-test outcomes to the (gold standard) BPTs outcomes in terms of sensitivity and specificity.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old visiting the outpatient clinic pulmonology with the suspicion of asthma will be asked to participate in this study. For reasons of external validity and generalizability of the study results, it was decided not to exclude subgroups such as smokers or obese patients.

Exclusion Criteria:

* Patients with already diagnosed asthma are not allowed to participate.
* The inclusion of patients with respiratory infections \<3 weeks ago will be postponed to \>3 weeks.

Primary outcomes:
measure: Number of provocation tests per year
timeFrame: 1 year
Secondary outcomes:
measure: Costs per year
timeFrame: 1 year
measure: Burden for the patient per through study completion
timeFrame: 1 year
measure: Accurancy FeNO-test through study completion
timeFrame: 1 year
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Hanna Kuiper-van der Valk
state: Zuid-Holland
Study officials:
References: