Diagnostic accuracy of minimally-invasive biomarkers for sputum eosinophilia in adult-onset asthma patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27218

Enrollment

336

Registered

2014-05-12

Start date

2014-05-13

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

adult-onset asthma sputum eosinophilia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Age: 18-75 years Physician’s diagnosis of asthma, combined with documented reversibility in FEV1 of > 12% of predicted value or a positive inhaled methacholine provocation test (PC20 20% (with twice daily reading >10%)

Exclusion criteria

Exclusion criteria: Smoking history of >10 pack years combined with fixed airflow obstruction (FEV1 <80% of predicted and FEV1/FVC <0.70) without reversibility in FEV1 <12% or with a diffusion capacity <80% (TLCO/VA). Other pulmonary diseases. Non-related major co-morbidities. Pregnancy. Physician’s diagnosis of childhood asthma or other chronic respiratory diseases in childhood, frequent episodes of dyspnea as a child, or use of a bronchodilator or other asthma medication in childhood. Patients without sputum eosinophils results (reference test).

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of FeNO, IgE and blood eosinophils in detecting patients with sputum eosinophila ≥3%, as expressed by the: a) AUC b) sensitivity and corresponding threshold at a fixed specificity of 95% c) specificity (95%CI) and corresponding threshold at a fixed sensitivity of 95%.	—

Secondary

Measure	Time frame
-Evaluate the diagnostic accuracy of FeNO, IgE and blood eosinophils in patient subgroups (eg, gender, race, smoking status, oral corticosteroid treatment status, asthma severity, BMI, nasal polyps, atopy). -Evaluate whether combinations of FeNO, IgE and blood eosinophils improved diagnostic accuracy, as determined by the AUC. -Build a multivariable logistic regression model including patient characteristics and marker combinations for the optimal discrimination between patients with and without sputum eosinophilia.	—

Measure

Time frame

-Evaluate the diagnostic accuracy of FeNO, IgE and blood eosinophils in patient subgroups (eg, gender, race, smoking status, oral corticosteroid treatment status, asthma severity, BMI, nasal polyps, atopy). -Evaluate whether combinations of FeNO, IgE and blood eosinophils improved diagnostic accuracy, as determined by the AUC. -Build a multivariable logistic regression model including patient characteristics and marker combinations for the optimal discrimination between patients with and without sputum eosinophilia.

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Contacts

Public ContactG.A. Westerhof

Department of Respiratory Medicine, F5-260 Academic Medical Centre, University of Amsterdam PO Box 22700, 1100 DE Amsterdam

G.A.Westerhof@amc.uva.nl+31 - 20 - 56 61660

Outcome results