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
ID
Bron
Verkorte titel
Aandoening
asthma, reslizuamb, small airways, CT-scanning
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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)
Doel van het onderzoek
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
Onderzoeksopzet
screening, baseline visit (t=0), visit 2 (t=4 wk), visit 3 (t=8 wk), end of study visit (t=12 wk)
Onderzoeksproduct en/of interventie
Patients will recieve reslizuamb (n=21) or placebo (n=11) administered intravenously every 4 weeks for 12 consecutive weeks
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7287 |
| NTR-old | NTR7496 |
| CCMO | NL63056.018.18 |
| OMON | NL-OMON55433 |