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

NCT ID: NCT06230458

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-10-01

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.

Conditions

Diagnosis; Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Asthma patients without reversibility

Asthma patients without reversibility

Group Type: OTHER

FeNO-test

Intervention Type: DIAGNOSTIC_TEST

Fractional Exhaled Nitric Oxide (FeNO)- test

Interventions

FeNO-test

Fractional Exhaled Nitric Oxide (FeNO)- test

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OLVG

NETWORK

Sponsor Role: collaborator

Franciscus Gasthuis & Vlietland (Hospital)

OTHER

Sponsor Role: lead

Responsible Party

Hanna Kuiper- van der Valk

Principal investgator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanna Kuiper-van der Valk

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Hanna Kuiper-van der Valk, Dr

Role: CONTACT

h.kuiperv-andervalk@franciscus.nl

+31642192700

Gert-Jan Braunstahl, Dr

Role: CONTACT

G.J.Braunstahl@franciscus.nl

Other Identifiers

R23.005

Identifier Type: -

Identifier Source: org_study_id