Using a FeNO test to improve asthma diagnosis
Care Evaluation Study of the Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma
This study is testing if adding a simple breath test for nitric oxide can make it easier and cheaper to diagnose asthma while also improving patients' quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 171 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Franciscus Gasthuis & Vlietland (Hospital) Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06230458 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of incorporating the Fractional Exhaled Nitric Oxide (FeNO) test into the asthma diagnostic process. It compares the traditional diagnostic approach, which includes spirometry and bronchial provocation tests (BPT), with a new method that uses the FeNO test as an intermediate step. The study aims to determine if this new approach can reduce the number of BPTs required, lower costs, and lessen the burden on patients. The trial will also assess the accuracy of the FeNO test and its impact on patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are visiting a pulmonology outpatient clinic with suspected asthma.
Not a fit: Patients who already have a diagnosis of asthma will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a more efficient and less burdensome asthma diagnosis process for patients.
How similar studies have performed: Other studies have shown promise in using FeNO testing for asthma diagnosis, suggesting this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rotterdam, South Holland
- Hanna Kuiper-van der Valk — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Hanna Kuiper-van der Valk, Dr
- Email: h.kuiperv-andervalk@franciscus.nl
- Phone: +31642192700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.