Impact analysis of the Fractional exhaled Nitric Oxide (FeNO) test as add-on test in the diagnostic work-up of asthma

Recruiting

• Conditions: Asthma; 10006436

• Registration Number: NL-OMON53629
• Lead Sponsor: Franciscus Gasthuis & Vlietland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 171

Inclusion Criteria

• Patients >= 18 years, referred by the general practitioner to the outpatient
clinic pulmonology with the suspicion of asthma
• Patients without reversibility at the spirometry (delta FEV1 >= 200 ml and
>=12% improvement)
• Patients understand the Dutch or English language for giving informed consent
and to complete the questionnaires
• They can discontinue their medication (discontinuation time depends on the
kind of medication, paragraph 3.2)

Exclusion Criteria

Patients will be excluded if:
• They have a fixed obstruction or with already the diagnose with asthma based
on prior tests
• They are pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoint:<br /><br>• (Theoretical) reduction of BPTs</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>• Direct healthcare costs of diagnosis (avoidable BPTs, extra costs of FeNOs,<br /><br>extra diagnose costs in FeNO >= 50 ppb and negative BPT)<br /><br>• The diagnostic burden of FeNO testing and BPT testing (VAS -score and AQLQ)<br /><br>• Asthma control (ACQ)<br /><br><br /><br><br /><br>Secondary parameters:<br /><br>- Patient characteristics<br /><br>- Asthma profile (eosinophils, sIgE to inhalation allergens)<br /><br>- Lung function (FEV1 and Forced Vital Capacity (FVC) and FVC/ FEV1)<br /><br>- Outcome BPT (positive/negative)<br /><br>- FeNO test outcome (ppb)</p><br>