E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | 1.Patients with severe eosinophilic asthma | Ernstig eosinofiel astma patiënten | |
E.1.1.1 | Medical condition in easily understood language | Patients with severe eosinophilic asthma | Ernstig eosinofiel astma patiënten | |
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10068462 | E.1.2 | Term | Eosinophilic asthma | E.1.2 | System Organ Class | 100000004855 | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | 1.To investigate the effect of 3 months treatment with Reslizumab on air trapping, by using different techniques | Het effect van 3 maanden behandeling met Reslizumab op air trapping met verschillende technieken bepaald | |
E.2.2 | Secondary objectives of the trial | 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. | De mate van hyperinflatie bepalen bij patiënten met eosinofiel astma en dit relateren aan het percentage eosinofielen in perifeer bloed en sputum | |
E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives | Not applicable | Niet van toepassing | |
E.3 | Principal inclusion criteria | •Blood eosinophil counts ≥0.4 x 10E9/L despite adequate treatment with high doses of inhaled corticosteroids (>800mcg/day fluticaone equivalent) | Bloed eosinofilien ≥0.4 x 10E9/L ondanks behandeling met hoge dosis inhalatie medicatie (>800mcg/dd fluticasone | |
E.4 | Principal 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. | Hyper eosinofiel syndroom, Churg Strauss of eosinofiel oesofagitis | |
E.5 End points |
E.5.1 | 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. | de verandering op baseline van iVlobes en iVaw na s maanden Reslizumab behandeling vergeleken met placebo | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | Baseline and 12 weeks | Baseline en 12 weeks | |
E.5.2 | 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. | Kwaliteit van leven vragenlijsten, longfunctie, stikstof meting, bepaling eosinofielen in bloed en sputum en FRI | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | Baseline and 12 weeks | Baseline en 12 weeks | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 | The trial involves single site in the Member State concerned | Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | LVLS | Laatst visite, laatste patiënt | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |