Effect of Reslizumab on small airways in asthma - RESSAPEA

Conditions: asthma, reslizuamb, small airways, CT-scanning

Registration Number: NL-OMON29078

Lead Sponsor: Amsterdam University Medical Centre, University of Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 33

Inclusion Criteria

Patients will be aged 18 - 75 years and have a confirmed diagnosis of severe eosinophilic asthma according to ERS/ATS guidelines. All patients will show persistent blood eosinophilia of >0.4 x 10E9/L despite treatment with high doses of inhaled corticosteroids (>1000 ug/day fluticasone equivalent), or >0.15 x 10E9/L despite chronic oral corticosteroid treatment

Exclusion Criteria

•Current smokers or former smokers with a smoking history of ≥15 pack years. A former smoker is defined as a subject who quit smoking at least 6 months prior to Visit 1

•Chronic pulmonary disorders other than asthma

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In this study the change from baseline in regional image (HRCT) based hyperinflation (iVlobes) and in iVaw after 12 weeks treatment with reslizumab compared to changes in the placebo group

Secondary Outcome Measures

Name	Time	Method
iRaw, air trapping, internal lobar airflow distribution, low attenuation or emphysema score, blood vessel density, airway wall thickness. Also correlations between changes in HRCT parameters and SGRQ socire, AQLQ score, FEV1/FVC, FVC, FRC, RV/TLC, FeNO and sputum eosinophils will be assessed.