An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Cephalon Sponsored Study in Eosinophilic Asthma
- Conditions
- eosinophlic asthma10006436
- Registration Number
- NL-OMON36581
- Lead Sponsor
- Cephalon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 6
(a) The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma and who completed treatment in a Cephalon-sponsored, double-blind, placebo-controlled study in patients with eosinophilic asthma.
(b) Patient must have completed treatment in a previous Cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
(c) The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
- 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 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 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>* adverse events will be evaluated throughout the study<br /><br>* chemistry, hematology, and urinalysis tests (except for urine beta human<br /><br>chorionic gonadotropin<br /><br>[*-HCG] test conducted predose every 4 weeks) will be performed at baseline<br /><br>(end-of-treatment visit<br /><br>of previous double-blind study), at weeks 4, 8, and 24, and every 24 weeks<br /><br>thereafter until<br /><br>end-of-treatment visit/early termination, and 90 days after the<br /><br>end-of-treatment visit for blood<br /><br>eosinophils.<br /><br>* vital sign measurements, brief physical examinations, and concomitant<br /><br>medication usage will be<br /><br>assessed every 4 weeks throughout the study, and 90 days after the<br /><br>end-of-treatment visit.<br /><br>* antibodies to reslizumab will be assessed every 24 weeks until<br /><br>end-of-treatment visit/early<br /><br>termination</p><br>
- Secondary Outcome Measures
Name Time Method <p>* change from baseline in pulmonary function test results as measured by FEV1,<br /><br>%FEV1, FVC, and<br /><br>FEF25-75% every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks<br /><br>thereafter until<br /><br>end-of-treatment visit, or early termination<br /><br>* change from baseline in beta-agonist use every 4 weeks for 16 weeks, at 24<br /><br>weeks, and every 12<br /><br>weeks thereafter until end-of-treatment visit, or early termination<br /><br>* change from baseline in ASUI every 4 weeks for 16 weeks, at 24 weeks, and<br /><br>every 12 weeks<br /><br>thereafter until end-of-treatment visit, or early termination<br /><br>* change from baseline in ACQ score every 4 weeks for 16 weeks, at 24 weeks,<br /><br>and every 12 weeks<br /><br>thereafter until end-of-treatment visit, or early termination<br /><br>* change from baseline in AQLQ score every 24 weeks until end-of-treatment<br /><br>visit, or early termination</p><br>