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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Hanna Kuiper-van der Valk
RECRUITING
Rotterdam
Contact Information
Primary
Hanna Kuiper-van der Valk, Dr
h.kuiperv-andervalk@franciscus.nl
+31642192700
Backup
Gert-Jan Braunstahl, Dr
G.J.Braunstahl@franciscus.nl
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 171
Treatments
Other: Asthma patients without reversibility
Asthma patients without reversibility
Related Therapeutic Areas
Sponsors
Leads: Franciscus Gasthuis & Vlietland (Hospital)
Collaborators: OLVG

This content was sourced from clinicaltrials.gov