No registrations found.
ID
Source
Brief title
Health condition
asthma, reslizuamb, small airways, CT-scanning
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
Patients with severe asthma have a high disease burden because their disease remains poorly controlled despite high doses of inhaled asthma medications or even chronic oral corticosteroids. For these patients novel anti-inflammatory therapies have recently become available. Reslizumab is a humanized monoclonal antibody against interleukin-5, which has been shown efficacy in patients with severe eosinophilic asthma. The exact underlying pathophysiologic mechanism of reslizumab effects is unclear, but might be due to reduced inflammation and improved patency of the small airways with subsequent reduction in air trapping and dynamic hyperinflation. In the present study we will investigate in a randomized double blind placebo controlled trial the effect of 3 months reslizumab treatment on the volume of trapped air, measured by an innovative imaging technique in patients with severe eosinophilic asthma (blood eosinophils > 0.4 x 10E9/L)
Study objective
We hypothesize that the beneficial effetc of Reslizuamb in patients with severe eosinophilic asthma is primarily explained by improvement in small airways function and associated air trapping
Study design
screening, baseline visit (t=0), visit 2 (t=4 wk), visit 3 (t=8 wk), end of study visit (t=12 wk)
Intervention
Patients will recieve reslizuamb (n=21) or placebo (n=11) administered intravenously every 4 weeks for 12 consecutive weeks
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
• Chronic diseases other than asthma that are not controlled
• Current malignancy or previous malignancy in remission <12 months
• Monoclonal Antibodies other than Xolair to treat inflammatory disease within 3 hall-lives of visit 1
• Any other condition that, according to the investigator, may affect the outcome of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7287 |
| NTR-old | NTR7496 |
| CCMO | NL63056.018.18 |
| OMON | NL-OMON55433 |