Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma

Asthma Clinical Trial

— INFERNO  

Official title:

Care Evaluation Study of the Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230458
• Other study ID #: R23.005
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: January 2024
• Source: Franciscus Gasthuis & Vlietland (Hospital)
• Contact: Hanna Kuiper-van der Valk, Dr
• Phone: +31642192700
• Email: h.kuiperv-andervalk[@]franciscus.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 171
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Diagnosis

Intervention

Diagnostic Test:
• FeNO-test
Fractional Exhaled Nitric Oxide (FeNO)- test

Locations

Country	Name	City	State
Netherlands	Hanna Kuiper-van der Valk	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Franciscus Gasthuis & Vlietland (Hospital)	OLVG

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of provocation tests per year		1 year
Secondary	Costs per year		1 year
Secondary	Burden for the patient per through study completion		1 year
Secondary	Accurancy FeNO-test through study completion		1 year