Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older visiting the pulmonology outpatient clinic with suspected asthma
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
Trial Site Locations
Total: 1 location
1
Hanna Kuiper-van der Valk
Rotterdam, South Holland, Netherlands, 3045PM
Actively Recruiting
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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