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Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab

NCT03074942 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-05-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Reslizumab

Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Sociedad Española de Neumología y Cirugía Torácica

    lead OTHER

Principal Investigators

  • Luis Pérez de Llano, MD · Hospital Universitario Lucus Augusti

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2018-03-26
Completion
2018-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03074942 on ClinicalTrials.gov