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

Completed

Conditions: adult-onset asthmasputum eosinophilia

Registration Number: NL-OMON27218

Lead Sponsor: Academic Medical Center, Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 336

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 < 8mg/ml) or diurnal variation in PEF of >20% (with twice daily reading >10%)

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
-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). <br /> <br>-Evaluate whether combinations of FeNO, IgE and blood eosinophils improved diagnostic accuracy, as determined by the AUC.<br /><br>-Build a multivariable logistic regression model including patient characteristics and marker combinations for the optimal discrimination between patients with and without sputum eosinophilia.