Study to evaluate the efficacy as measured by the reduction of exacerbations & change in lung function & safety of a drug called reslizumab performed by comparing simultaneously 2 groups of patients aged from 12 - 75 years suffering from eosinophilic asthma & receiving during 12 months either reslizumab (at a dose of 3mg/kg) or a placebo (inactive substance). Treatment given to each patient will be drawn at random without both the patient and the physician knowing which one has been attributed
- Conditions
- Treatment for patients with eosinophilic asthmaMedDRA version: 14.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2010-024614-66-CZ
- Lead Sponsor
- Teva Branded Pharmaceutical Products, R&D, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 480
(a)The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma.
(b)Inclusion criterion (b) is replaced by (b1).
(b1) The patient has had at least 1 asthma exacerbation requiring oral, intramuscular, or intravenous (iv) corticosteroid use for at least 3 days over the past 12 months before screening.
(c)The patient has a current blood eosinophil level of at least 400/?L.
(d)The patient has airway reversibility of at least 12% to beta-agonist administration.
(e)Inclusion criterion (e) is replaced by (e1).
(e1) The patient has an ACQ score of at least 1.5 at the screening and baseline (before the 1st dose of study drug) visits.
(f)Inclusion criterion (f2) is replaced by (f3).
(f3) The patient is taking inhaled fluticasone at a dosage of at least 440 µg, or equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of oral corticosteroid treatment at the time of study enrollment, the patient must remain on this dose throughout the study. The patient’s baseline asthma therapy regimen (including, but not limited to, inhaled corticosteroids, oral corticosteroids up to a maximum dose of 10 mg prednisone daily or equivalent, leukotriene antagonists, 5 lipoxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline and must continue without dosage changes throughout the study.
(g)All female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test beta human chorionic gonadotropin (ß HCG) at screening (serum) and baseline (urine).
(h)Inclusion criterion (h1) is replaced by (h2).
(h2) 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. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). NOTE: Partner sterility alone is not acceptable for inclusion in the study.
(i)Written informed consent is obtained. Patients 12 through 17 years old must provide assent.
(j)Inclusion criterion (j) is replaced by (j1).
(j1) The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, ECG evaluation (at screening), serum chemistry, hematology, and urinalysis.
(k)Inclusion criterion (k) is replaced by (k1).
(k1) The patient must be willing and able to understand and comply with study restrictions, requirements, and procedures, as specified by the study center, and to remain at the study center for the required duration during the study period, and willing to return to the study center for the follow up evaluation as specified in this protocol.
(l)Patients who experience an asthma exacerbation during the screening period will be considered to have failed screening and cannot be randomly assigned to study drug. Patients may be rescreened 1 time only.
Are the trial subjects under 18? yes
Number of subjects for this age range: 44
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects
(a)The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient’s safety.
(b)The patient has known hypereosinophilic syndrome.
(c)Exclusion criterion (c) is replaced by (c1).
The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) will also be excluded.
(d)The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
(e)Exclusion criterion (e2) is replaced by (e3).
(e3) The patient is using systemic immunosuppressive, immunomodulating, or other biologic agents (including, but not limited to, anti IgE mAb, methotrexate, cyclosporin, interferon a, or
anti–tumor necrosis factor [anti TNF] mAb) within 6 months prior to screening.
(f)Exclusion criterion (f1) is replaced by (f2).
(f2) The patient has previously received an anti-hIL-5 monoclonal antibody (eg, reslizumab, mepolizumab, or benralizumab).
(g)Exclusion criterion (g) is replaced by (g1).
(g1) The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).
(h)The patient has participated in any investigative drug or device study within 30 days prior to study screening.
(i)Exclusion criterion (i1) is replaced by (i2).
(i2) The patient has participated in any investigative biologics study within 6 months prior to screening.
(j)Exclusion criterion (j1) is replaced by (j2).
(j2) Female patients who are pregnant, nursing, or, if of childbearing potential, and not using a medically accepted, effective method of birth control (eg, barrier method with spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study. NOTE: Partner sterility alone is not considered an acceptable form of birth control.
(k)The patient has concurrent infection or disease that may preclude assessment of active asthma.
(l)Exclusion criterion (l) is replaced by (l1).
(l1) The patient has a history of concurrent immunodeficiency (human immunodeficiency virus [HIV] or acquired immunodeficiency syndrome or congenital immunodeficiency).
(m)The patient has current suspected drug and alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM IV TR) criteria.
(n)Exclusion criterion (n) is replaced by (n1).
(n1) The patient has had an active parasitic infection within 6 months prior to screening.
(o)The patient may not have received any live attenuated vaccine within the 12 week period prior to screening.
(p)The patient has a history of allergic reactions to or hypersensitivity to any component of the study drug.
(q)The patient has had an infection requiring the following:
?an admission to the hospital for at least 24 hours within 4 weeks prior to screening or during the screening period
?treatment with iv antibiotics within 4 weeks prior to screening or during the screening period
?treatment with oral antibiotics within 4 weeks prior to screening or during the screening period
(r)The patient has a history of exposure to water borne parasites within 6 weeks prior to screening or during the screening period o
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method