NCT06230458 Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma
| NCT ID | NCT06230458 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Franciscus Gasthuis & Vlietland (Hospital) |
| Condition | Diagnosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 171 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 171 participants in total. It began in 2023-10-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06230458 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diagnosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06230458 currently recruiting?
Yes, NCT06230458 is actively recruiting participants. Contact the research team at h.kuiperv-andervalk@franciscus.nl for enrollment information.
Where is the NCT06230458 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT06230458 clinical trial?
NCT06230458 is sponsored by Franciscus Gasthuis & Vlietland (Hospital). The trial plans to enroll 171 participants.