Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06230458

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

Led by Franciscus Gasthuis & Vlietland (Hospital) · Updated on 2024-01-30

171

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

F

Franciscus Gasthuis & Vlietland (Hospital)

Lead Sponsor

O

OLVG

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older visiting the pulmonology outpatient clinic with suspected asthma
Not Eligible

You will not qualify if you...

  • Patients with a previous diagnosis of asthma
  • Patients with respiratory infections within the last 3 weeks (inclusion postponed until after 3 weeks)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hanna Kuiper-van der Valk

Rotterdam, South Holland, Netherlands, 3045PM

Actively Recruiting

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Research Team

H

Hanna Kuiper-van der Valk, Dr

CONTACT

G

Gert-Jan Braunstahl, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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