Eosinophilic Asthma Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 315 |
Est. completion date | December 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 75 Years |
Eligibility |
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 Argentina. - 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 (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) 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 the end-of-treatment visit. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). - Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards. - Other inclusion criteria apply. 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 (HES). - 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 aspergillosis). - 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-a, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (screening). - The patient is currently using systemic corticosteroids (includes use of oral corticosteroids). - The patient has a current infection or disease that may preclude assessment of asthma. - The patient is expected to be poorly compliant with study drug administration, study procedures, or visits. - The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease). - The patient has participated in any investigative drug or device study within 30 days prior to screening. - The patient has participated in any investigative biologics study within 90 days prior to screening. - The patient has previously received anti-hIL-5 monoclonal antibody (eg, mepolizumab). - Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (e.g. spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) 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 HIV performed during screening. - Other exclusion criteria apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Teva Investigational Site 121 | Ciudad Autonoma de Buenos Aire | |
Argentina | Teva Investigational Site 126 | Ciudad Autonoma de Buenos Aire | |
Argentina | Teva Investigational Site 127 | Ciudad Autonoma de Buenos Aire | |
Argentina | Teva Investigational Site 128 | Quilmes-Buenos Aires | |
Argentina | Teva Investigational Site 125 | Rosario | |
Argentina | Teva Investigational Site 123 | Rosario-Santa Fe | |
Argentina | Teva Investigational Site 120 | San Miguel de Tucuman - Tucuma | |
Argentina | Teva Investigational Site 122 | San Miguel de Tucuman - Tucuma | |
Argentina | Teva Investigational Site 124 | San Miguel de Tucuman - Tucuma | |
Belgium | Teva Investigational Site 261 | Bruxelles | |
Belgium | Teva Investigational Site 264 | Bruxelles | |
Belgium | Teva Investigational Site 260 | Gent | |
Belgium | Teva Investigational Site 263 | Liège | |
Brazil | Teva Investigational Site 146 | Belo Horizonte | |
Brazil | Teva Investigational Site 150 | Florianopolis | |
Brazil | Teva Investigational Site 140 | Porto Alegre | |
Brazil | Teva Investigational Site 143 | Porto Alegre | |
Brazil | Teva Investigational Site 144 | Porto Alegre | |
Brazil | Teva Investigational Site 145 | Porto Alegre | |
Brazil | Teva Investigational Site 147 | Porto Alegre - RS | |
Brazil | Teva Investigational Site 142 | Santo André, São Paulo | |
Brazil | Teva Investigational Site 141 | Sao Paulo | |
Canada | Teva Investigational Site 103 | Calgary | |
Canada | Teva Investigational Site 101 | Montreal | |
Canada | Teva Investigational Site 104 | Newmarket | |
Canada | Teva Investigational Site 105 | Windsor | |
Colombia | Teva Investigational Site 184 | Bogota | |
Colombia | Teva Investigational Site 185 | Bogota | |
Colombia | Teva Investigational Site 181 | Bogotá | |
Colombia | Teva Investigational Site 182 | Cali | |
Colombia | Teva Investigational Site 180 | Floridablanca | |
Colombia | Teva Investigational Site 183 | Medellin | |
France | Teva Investigational Site 343 | Grenoble | |
France | Teva Investigational Site 342 | Marseille | |
France | Teva Investigational Site 341 | Montpellier | |
France | Teva Investigational Site 340 | Nantes | |
France | Teva Investigational Site 344 | Pessac | |
Hungary | Teva Investigational Site 401 | Balassagyarmat | |
Hungary | Teva Investigational Site 406 | Edelény | |
Hungary | Teva Investigational Site 400 | Miskolc | |
Hungary | Teva Investigational Site 404 | Mosonmagyaróvár | |
Hungary | Teva Investigational Site 403 | Sopron | |
Hungary | Teva Investigational Site 407 | Százhalombatta | |
Hungary | Teva Investigational Site 402 | Tatabánya | |
Israel | Teva Investigational Site 422 | Petach Tikva | |
Israel | Teva Investigational Site 421 | Rehovot | |
Israel | Teva Investigational Site 420 | Tel-Aviv | |
Mexico | Teva Investigational Site 203 | Distrito Federal | |
Mexico | Teva Investigational Site 205 | Distrito Federal | |
Mexico | Teva Investigational Site 204 | Guadalajara, JAL | |
Mexico | Teva Investigational Site 200 | Hermosillo, Sonora | |
Mexico | Teva Investigational Site 202 | Tijuana, B.C. | |
Netherlands | Teva Investigational Site 460 | Heerlen | |
Poland | Teva Investigational Site 507 | Bialystok | |
Poland | Teva Investigational Site 513 | Gdansk | |
Poland | Teva Investigational Site 512 | Lodz | |
Poland | Teva Investigational Site 505 | Lublin | |
Poland | Teva Investigational Site 500 | Ostrow Wielkopolski | |
Poland | Teva Investigational Site 502 | Sopot | |
Poland | Teva Investigational Site 504 | Tarnow | |
Sweden | Teva Investigational Site 602 | Göteborg | |
Sweden | Teva Investigational Site 600 | Lund | |
Sweden | Teva Investigational Site 601 | Malmö | |
United States | Teva Investigational Site 12 | Anaheim | California |
United States | Teva Investigational Site 21 | Charleston | South Carolina |
United States | Teva Investigational Site 20 | Cincinnati | Ohio |
United States | Teva Investigational Site 2 | Colorado Springs | Colorado |
United States | Teva Investigational Site 16 | Fort Worth | Texas |
United States | Teva Investigational Site 11 | Fountain Valley | California |
United States | Teva Investigational Site 10 | Houston | Texas |
United States | Teva Investigational Site 7 | Iowa City | Iowa |
United States | Teva Investigational Site 24 | Largo | Florida |
United States | Teva Investigational Site 6 | Lilburn | Georgia |
United States | Teva Investigational Site 73 | Lincoln | Rhode Island |
United States | Teva Investigational Site 43 | Los Angeles | California |
United States | Teva Investigational Site 1 | Medford | Oregon |
United States | Teva Investigational Site 27 | Miami | Florida |
United States | Teva Investigational Site 5 | Miami | Florida |
United States | Teva Investigational Site 8 | Omaha | Nebraska |
United States | Teva Investigational Site 4 | Orange | California |
United States | Teva Investigational Site 9 | Providence | Rhode Island |
United States | Teva Investigational Site 14 | San Antonio | Texas |
United States | Teva Investigational Site 45 | San Antonio | Texas |
United States | Teva Investigational Site 3 | Savannah | Georgia |
United States | Teva Investigational Site 26 | Summit | New Jersey |
United States | Teva Investigational Site 19 | Tallahassee | Florida |
United States | Teva Investigational Site 17 | Trinity | Florida |
United States | Teva Investigational Site 18 | Valrico | Florida |
United States | Teva Investigational Site 15 | Walnut Creek | California |
Lead Sponsor | Collaborator |
---|---|
Cephalon |
United States, Argentina, Belgium, Brazil, Canada, Colombia, France, Hungary, Israel, Mexico, Netherlands, Poland, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall change from baseline as assessed by Forced Expiratory Volume in 1 second (FEV1) | baseline to week 16 (or early withdrawal) | baseline to week 16 | No |
Secondary | Lung function as measured by percent predicted Forced Expiratory Volume in 1 second (% predicted FEV1) | from baseline to weeks 4, 8, 12, 16 or early withdrawal | baseline to week 16 | No |
Secondary | Lung function as measured by Forced Vital Capacity (FVC) | from baseline to weeks 4, 8, 12, 16 or early withdrawal | baseline to week 16 | No |
Secondary | Lung function as measured by Forced Expiratory Flow at 25% to 75% of FVC (FEF25-75%) | from baseline to weeks 4, 8, 12, 16 or early withdrawal | baseline to week 16 | No |
Secondary | Short-acting beta-agonist use | from baseline to weeks 4, 8, 12, 16 or early withdrawal | baseline to week 16 | No |
Secondary | Blood eosinophil count | from baseline to weeks 4, 8, 12, 16 and follow-up or early withdrawal | baseline to week 16 | No |
Secondary | Asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI) | from baseline to weeks 4, 8, 12, 16 or early withdrawal | baseline to week 16 | No |
Secondary | Asthma control as measured by the Asthma Control Questionnaire (ACQ) | from baseline to weeks 4, 8, 12, 16 or early withdrawal | baseline to week 16 | No |
Secondary | Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) | from baseline to week 16 or early withdrawal | baseline to week 16 | No |
Secondary | Evaluate the safety and tolerability of reslizumab treatment | 16 weeks + 90 day follow-up: occurrence of adverse events clinical laboratory test results vital signs (blood pressures, pulse, body temperature, and respiratory rate) measurements at weeks 4, 8, 12, and 16 or early withdrawal and 90 (±7) days after the end-of treatment evaluation. physical examination findings, including body weight measurements, at weeks 4, 8, 12, and 16 or early withdrawal 12-lead electrocardiography (ECG) findings at week 16 or early withdrawal concomitant medication usage throughout the study |
7 months | Yes |
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