Asthma
Conditions
Interventions
Patients will receive Reslizumab (n=22) or placebo (n=11) administered
intravenously every 4 weeks for 3 consecutive months.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: severe asthma; Blood eosinophil counts >=0.4 x 10E9/L despite adequate treatment with high doses of inhaled corticosteroids (>1000mcg/day fluticasone equivalent)
Exclusion criteria
Exclusion criteria: Subjects with other conditions that could lead to elevated eosinophils such as Hyper eosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis. malignancies; use of other monoclonals (except omalizumab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| in this study is the change from baseline in regional image based hyperinflation (iVlobes) and in iVaw after 3 months Reslizumab treatment compared to changes in the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| iRaw, air trapping, 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 patient-reported outcomes, FEV1/FVC, FVC, FRC, RV/TLC, FeNO will be assessed. | — |
Countries
Netherlands
Outcome results
None listed