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

NCT06230458 | Recruiting

• 1 other identifier: R23.005
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnosis; Asthma

Keywords

Asthma; Diagnostics; FeNO; Bronchial provocation test; Burdesome; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Number of provocation tests per year

  1 year

Secondary Outcomes (3)

• Costs per year

  1 year

• Burden for the patient per through study completion

  1 year

• Accurancy FeNO-test through study completion

  1 year

Study Arms (1)

Asthma patients without reversibility

OTHER

Asthma patients without reversibility

Diagnostic Test: FeNO-test

Interventions

FeNO-test DIAGNOSTIC_TEST

Fractional Exhaled Nitric Oxide (FeNO)- test

Asthma patients without reversibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with already diagnosed asthma are not allowed to participate.

Sponsors & Collaborators

• Franciscus Gasthuis & Vlietland (Hospital): lead
• OLVG: collaborator

Study Sites (1)

Hanna Kuiper-van der Valk

Rotterdam, South Holland, 3045PM, Netherlands

RECRUITING

MeSH Terms

Conditions

Disease; Asthma

Interventions

Fractional Exhaled Nitric Oxide Testing

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Breath Tests; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Hanna Kuiper-van der Valk, Dr

CONTACT

+31642192700; h.kuiperv-andervalk@franciscus.nl

Gert-Jan Braunstahl, Dr

CONTACT

G.J.Braunstahl@franciscus.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investgator

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 30, 2024
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)