Effect of Reslizumab on small airways in asthma. RESSAPEA

Phase 1

Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
1.Patients with severe eosinophilic asthma
MedDRA version: 20.0Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855

Registration Number: EUCTR2017-003958-16-NL

Lead Sponsor: Academic Medical Center, University of Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 33

Inclusion Criteria

•Blood eosinophil counts =0.4 x 10E9/L despite adequate treatment with high doses of inhaled corticosteroids (>800mcg/day fluticaone equivalent)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

•Eosinophilic Diseases: Subjects with other conditions that could lead to elevated eosinophils such as Hyper eosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.To investigate the effect of 3 months treatment with Reslizumab on air trapping, by using different techniques;Secondary Objective: To investigate the degree of (dynamic) hyperinflation in patients with severe eosinophilic asthma, and relate it to the percentage of eosinophils in peripheral blood and sputum Study.;Primary end point(s): in this study is the change from baseline in regional image based hyperinflation (iVlobes ) and in (specific) iVaw after 3 months Reslizumab treatment compared to changes in the placebo group.;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (specific) iRaw, exploratory parameters from FRI, iVlung, air trapping specific imaged-based airway volume (s)iVaw) at TLC, internal lobar airflow distribution, low attenuation or emphysema score, blood vessel density, airway wall thickness and aerosol deposition concentrations, Also correlations between changes in HRCT parameters and SGRQ, AQLQ, ACQ, FEV1/FVC, FVC, FRC, RV/TLC, FeNO and cell differential counts in sputum and blood. ;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks