Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma
Recruiting · NCT06230458 · Interventional (participants receive a specific treatment) · Lead sponsor: Franciscus Gasthuis & Vlietland (Hospital)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Hanna Kuiper-van der Valk - Rotterdam, South Holland, Netherlands