A 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
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | December 2010 |
End Date: | June 2013 |
Contact: | Cephalon Contact |
Phone: | 1-877-237-4879 |
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
The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3
or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than
placebo in improving lung function in patients with eosinophilic asthma.
Inclusion Criteria:
- The patient is male or female, 12 through 75 years of age, with a previous diagnosis
of asthma. Patients 12 through 17 years of age are excluded from participating in
India and Argentina; patients 66 through 75 years of age are excluded from
participating in India.
- 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 μg daily (or
equivalent). Patients' baseline asthma therapy regimens must be stable for 30 days
before screening, and continue without dosage changes throughout study.
- The patient has a blood eosinophil count of at least 400/μL.
- Female patients must be surgically sterile, 2 years postmenopausal, or must have a
negative pregnancy test ßHCG at screening (serum) and baseline (urine).
- Female patients of childbearing potential (not surgically sterile or 2 years
postmenopausal), must use a medically accepted method of contraception and must agree
to continue use of this method for the duration of the study and for 30 days after
participation in the study.
- Written informed consent is obtained. Patients 12 through 17 years old, where
participating, need to provide assent in accordance with local standards.
Exclusion Criteria:
- 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 hypereosinophilic syndrome.
- The patient has another confounding underlying lung disorder (eg, chronic obstructive
pulmonary disease, pulmonary fibrosis, or lung cancer). The patient has other
pulmonary conditions with symptoms of asthma and blood eosinophilia (eg,
Churg-Strauss syndrome, allergic bronchopulmonary aspergilosis).
- The patient is a current smoker (ie, has smoked within the last 6 months prior to
screening).
- The patient has a history of use of systemic immunosuppressive or immunomodulating
agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis
factor mAb) within 6 months prior to study entry (randomization).
- Female patients who are pregnant, or nursing, or, if of childbearing potential and
not using a medically accepted, effective method of birth control (eg, spermicide,
abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and
injected] in conjunction with a barrier method) are excluded from this study.
- The patient has a current infection or disease that may preclude assessment of
asthma.
- The patient has a history of concurrent immunodeficiency (human immunodeficiency,
acquired immunodeficiency syndrome, or congenital immunodeficiency). Patients in
Argentina must have documented serology testing for human immunodeficiency virus
(HIV) performed during screening.
- The patient has presence of or suspected parasitic infestation/infection.
- Patients may not have received any live attenuated vaccine within the 12-week period
before study entry.
- The patient has a history of allergic reactions to or hypersensitivity to any
component of the study drug.
We found this trial at
26
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