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van CCT (UK)

van CCT (UK)

Effect of Reslizumab on small airways in asthma - RESSAPEA

- candidate number29580
- NTR NumberNTR7496
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-sep-2018
- Secondary IDsNL63056.018.18 METC AMC
- Public TitleEffect of Reslizumab on small airways in asthma - RESSAPEA
- Scientific TitleEffect of Reslizumab on small airways in asthma - RESSAPEA
- hypothesisWe 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
- Healt Condition(s) or Problem(s) studiedAsthma, Computed tomography, Airways, Reslizumab
- Inclusion criteriaPatients 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2018
- planned closingdate1-jul-2021
- Target number of participants33
- InterventionsPatients will recieve reslizuamb (n=21) or placebo (n=11) administered intravenously every 4 weeks for 12 consecutive weeks
- Primary outcomeIn 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 outcomeiRaw, 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.
- Timepointsscreening, baseline visit (t=0), visit 2 (t=4 wk), visit 3 (t=8 wk), end of study visit (t=12 wk)
- Trial web site
- statusplanned
- Sponsor/Initiator Amsterdam UMC, University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
Teva Pharma Netherlands BV
- Publications
- Brief summaryPatients 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)
- Main changes (audit trail)
- RECORD25-sep-2018 - 6-okt-2018

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