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

ConditionsDiagnosisAsthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFranciscus Gasthuis & Vlietland (Hospital)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • FeNO-test

    Diagnostic test

    Fractional Exhaled Nitric Oxide (FeNO)- test

Treatment groups

171 Participants
are divided into 1 treatment group
Group A: Asthma patients without reversibilityOther 1 intervention

Trial outcomes

Primary outcomes

1

Number of provocation tests per year

Time frame
1 year

Secondary outcomes

1

Costs per year

Time frame
1 year
2

Burden for the patient per through study completion

Time frame
1 year
3

Accurancy FeNO-test through study completion

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Franciscus Gasthuis & Vlietland (Hospital)

Lead sponsor

OLVG

Collaborator

Source ClinicalTrials.gov
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