A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) with Eosinophilic Asthma.
- Conditions
- eosinophlic asthma10006436
- Registration Number
- NL-OMON36320
- Lead Sponsor
- Cephalon Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
- The patient is a male or female 12 through 75 years of age with a previous diagnosis of asthma.
- The patient has an ACQ score of at least 1.5.
- The patient has airway reversibility of at least 12% to beta-agonist administration at screening.
- The patient is currently taking fluticasone at a dosage of at least 440 *g daily (or equivalent).
- The patient has a blood eosinophil count of at least 400/*L.
- The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient*s safety.
- The patient has known HES.
- The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
- The patient is a current smoker.
- The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-*, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (randomization).
- The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).
prior to screening.
- The patient has previously received anti-hIL-5 monoclonal antibody.
- The patient has a current infection or disease that may preclude assessment of asthma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable for this study is the change from baseline to<br /><br>endpoint in FEV1.</p><br>
- Secondary Outcome Measures
Name Time Method