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Evaluation of the diagnostic accuracy of FeNO in patients with suspected asthma: a prospective validation study

Evaluation of the diagnostic accuracy of FeNO in patients with suspected asthma: a prospective validation study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00021125
Enrollment
300
Registered
2020-06-24
Start date
2020-07-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J45

Interventions

Group 1: Adult patients suspected to suffer from asthma and who visit one of the participating practices of pneumologists will perform a FeNO measurement with the device NIOX VERO®. Afterwards, they w

Sponsors

Klinikum rechts der Isar, Institut für Allgemeinmedizin und Versorgungsforschung der Technischen Universität München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: All adult patients suspected to suffer from asthma, visiting one of the participating practices of pneumologists and who declare their written informed consent to participate in the study will be consecutively included.

Exclusion criteria

Exclusion criteria: Patients with the following criteria are not included: • Patients who do not agree to participate in this study • Patients younger than 18 years • Patients who do not understand the meaning of the study due to a lack of knowledge of the German language • Patients with an already diagnosed obstructive airway disease • Patients who smoked on the day of the examination (falsification of the FeNO measurement and bronchial provocation test) • Patients who have eaten a large amount of nitrate-rich diet (e.g. salad) before the examination (false high FeNO values) • Patients with airway infection = 6 weeks prior study enrolement (distortion of the FeNO measurement and/or bronchial provocation test)

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of FeNO measurement at a cut-off value of 50ppb for an asthma diagnosis

Secondary

MeasureTime frame
Positive predictive value (PPV) and negative predictive value (NPV) of FeNO measurement at a cut-off value of 50ppb regarding the diagnosis of asthma. Determination of PPV for an asthma diagnosis at a FeNO cut-off value of 33ppb, if the symptoms "Allergic rhinitis" and "Wheezing" are present. Additionally, the PPV at a FeNO cut-off value of 33ppb is determined regarding ICS responsiveness.

Countries

Germany

Contacts

Public ContactChristina Kellerer

Klinikum rechts der Isar, Institut für Allgemeinmedizin und Versorgungsforschung der Technischen Universität München

christina.kellerer@mri.tum.de+4989614658917

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 16, 2026