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| Name | Class |
|---|---|
| Teva Pharmaceuticals USA | INDUSTRY |
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Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of life in severe allergic asthmatics. However, approximately 25% of the treated patients fail to respond to this monoclonal antibody. The rest of them show different degrees of response, although the rate of asthmatics who achieve control of the disease is unknown because clinical trials of omalizumab have been carried out to assess the impact of the drug on exacerbations, symptoms or even pulmonary function, but its effect on control was not evaluated. Therefore, there is a need to find new therapeutic options for those severe asthmatics who remain uncontrolled despite having received all the recommended therapies (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary function and symptoms in patients with severe asthma and high peripheral eosinophil counts. It would be important to demonstrate that Reslizumab is able to improve the clinical condition of severe asthma patients with no therapeutic options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reslizumab | Experimental | Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reslizumab | Drug | Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Asthma Control Test score (ACT) | Change in Asthma Control Test score (ACT) between baseline and week 24. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Asthma Control Test (ACT) score | Change in ACT between baseline and week 12 | Baseline and 12 weeks |
| Change from baseline in the 7-item Asthma Control Questionnaire (ACQ). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Pérez de Llano, MD | Hospital Universitario Lucus Augusti | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Son Espases | Palma | Balearic Islands | 07120 | Spain | ||
| Hospital de Sabadell |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C515492 | reslizumab |
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Change in the 7-item ACQ between baseline and week 24.
| Baseline and 24 weeks |
| Percentage of patients that achieve the minimally important difference in ACT | Percentage of patients that achieve the minimally important difference in ACT (increase of at least 3 ponints) at week 24 | Baseline and 24 weeks |
| Percentage of patients that achieve the minimally important difference in ACQ-7 | Percentage of patients that achieve the minimally important difference in ACQ-7 (reduction of at least 0.5 ponints) at week 24 | Baseline and 24 weeks |
| Change from baseline in eosinophil count in peripheral blood. | Change from baseline in eosinophil count in peripheral blood at week 24. | Baseline and 24 weeks |
| Change from baseline in lung function (FEV1). | Change from baseline in lung function (FEV1) at week 24. | Baseline and 24 weeks |
| Number of severe exacerbations of asthma. | Number of severe exacerbations of asthma during the 24 weeks of the study. | 24 weeks |
| Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score. | Change from baseline in the AQLQ questionnaire score at week 24. | Baseline and 24 weeks |
| Change from baseline in exhaled nitric oxide levels. | Change from baseline in exhaled nitric oxide levels at week 24. | Baseline and 24 weeks |
| Number of participants with adverse events | Number of participants with adverse events | 24 weeks |
| Number of participants with severe adverse events | Number of participants with severe adverse events | 24 weeks |
| Sabadell |
| Barcelona |
| 08208 |
| Spain |
| Hospital Universitario de Cruces | Barakaldo | Bizkaia | 48903 | Spain |
| Hospital Galdakao-Usansolo | Galdakao | Vizcaya | 48960 | Spain |
| Hospital Clínic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Virgen Del Rocío | Seville | 41013 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |