Eosinophilic Asthma Clinical Trial
Official title:
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 Teva-Sponsored Study in Eosinophilic Asthma
The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.
Status | Terminated |
Enrollment | 1052 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Written informed consent is obtained. - 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. - 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. - other criteria may apply; please contact the investigator for more information. 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 another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). - The patient is a current smoker. - 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 (e.g., gastroesophageal reflux disease [GERD]). - 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, intrauterine device [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. - other criteria may apply; please contact the investigator for more information. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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 | |
Australia | Teva Investigational Site 641 | East Bentleigh | |
Australia | Teva Investigational Site 642 | Frankston | |
Australia | Teva Investigational Site 645 | Liverpool | |
Australia | Teva Investigational Site 643 | Nedlands | |
Belgium | Teva Investigational Site 261 | Bruxelles | |
Belgium | Teva Investigational Site 264 | Bruxelles | |
Belgium | Teva Investigational Site 260 | Gent | |
Belgium | Teva Investigational Site 262 | Jambes | |
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 144 | Porto Alegre | |
Brazil | Teva Investigational Site 147 | Porto Alegre - RS | |
Brazil | Teva Investigational Site 143 | Porto Alegre, RS | |
Brazil | Teva Investigational Site 142 | Santo André, São 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 | |
Chile | Teva Investigational Site 160 | Rancagua | |
Chile | Teva Investigational Site 164 | Santiago | |
Chile | Teva Investigational Site 161 | Temuco | |
Chile | Teva Investigational Site 162 | Valdivia | |
Chile | Teva Investigational Site 166 | Valparaiso | |
Colombia | Teva Investigational Site 185 | Bogota | |
Colombia | Teva Investigational Site 181 | Bogotá | |
Colombia | Teva Investigational Site 182 | Cali | |
Colombia | Teva Investigational Site 180 | Floridablanca | |
Czech Republic | Teva Investigational Site 284 | Breclav | |
Czech Republic | Teva Investigational Site 287 | Brno | |
Czech Republic | Teva Investigational Site 286 | Liberec | |
Czech Republic | Teva Investigational Site 280 | Olomouc | |
Czech Republic | Teva Investigational Site 281 | Olomouc | |
Czech Republic | Teva Investigational Site 285 | Olomouc | |
Czech Republic | Teva Investigational Site 283 | Tabor | |
Denmark | Teva Investigational Site 300 | Odense | |
France | Teva Investigational Site 342 | Marseille | |
France | Teva Investigational Site 341 | Montpellier | |
Germany | Teva Investigational Site 361 | Berlin | |
Germany | Teva Investigational Site 366 | Berlin | |
Germany | Teva Investigational Site 371 | Bochum | |
Germany | Teva Investigational Site 369 | Frankfurt | |
Germany | Teva Investigational Site 370 | Hamburg | |
Germany | Teva Investigational Site 372 | Koblenz | |
Germany | Teva Investigational Site 367 | Leipzig | |
Germany | Teva Investigational Site 363 | Mainz | |
Greece | Teva Investigational Site 380 | Athens | |
Hungary | Teva Investigational Site 401 | Balassagyarmat | |
Hungary | Teva Investigational Site 400 | Miskolc | |
Hungary | Teva Investigational Site 404 | Mosonmagyaróvár | |
Hungary | Teva Investigational Site 403 | Sopron | |
Hungary | Teva Investigational Site 407 | Szazhalombatta | |
Hungary | Teva Investigational Site 402 | Tatabánya | |
Hungary | Teva Investigational Site 405 | Törökbálint | |
Israel | Teva Investigational Site 423 | Ashkelon | |
Israel | Teva Investigational Site 432 | Haifa | |
Israel | Teva Investigational Site 425 | Jerusalem | |
Israel | Teva Investigational Site 428 | Jerusalem | |
Israel | Teva Investigational Site 426 | Kfar Saba | |
Israel | Teva Investigational Site 422 | Petach Tikva | |
Israel | Teva Investigational Site 433 | Ramat Gan | |
Israel | Teva Investigational Site 421 | Rehovot | |
Israel | Teva Investigational Site 420 | Tel-Aviv | |
Korea, Republic of | Teva Investigational Site 682 | Gwangju | |
Korea, Republic of | Teva Investigational Site 680 | Seoul | |
Korea, Republic of | Teva Investigational Site 681 | Seoul | |
Korea, Republic of | Teva Investigational Site 683 | Seoul | |
Korea, Republic of | Teva Investigational Site 686 | Seoul | |
Korea, Republic of | Teva Investigational Site 685 | Suwon | |
Malaysia | Teva Investigational Site 705 | Batu Caves | |
Malaysia | Teva Investigational Site 700 | Kuala Lumpur | |
Malaysia | Teva Investigational Site 702 | Kuala Lumpur | |
Malaysia | Teva Investigational Site 701 | Penang | |
Malaysia | Teva Investigational Site 704 | Taiping | |
Mexico | Teva Investigational Site 205 | Ciudad De México | |
Mexico | Teva Investigational Site 203 | Distrito Federal | |
Mexico | Teva Investigational Site 204 | Guadalajara, JAL | |
Mexico | Teva Investigational Site 200 | Hermosillo, Sonora | |
Mexico | Teva Investigational Site 207 | Mexico City | |
Mexico | Teva Investigational Site 209 | Monterrey | |
Mexico | Teva Investigational Site 202 | Tijuana, B.C. | |
Netherlands | Teva Investigational Site 460 | Heerlen | |
New Zealand | Teva Investigational Site 723 | Auckland | |
New Zealand | Teva Investigational Site 724 | Dunedin | |
New Zealand | Teva Investigational Site 727 | Hamilton | |
New Zealand | Teva Investigational Site 720 | Tauranga | |
New Zealand | Teva Investigational Site 721 | Wellington | |
Peru | Teva Investigational Site 223 | Cercado de Lima, Lima | |
Peru | Teva Investigational Site 220 | Lima | |
Peru | Teva Investigational Site 221 | Lima | |
Peru | Teva Investigational Site 222 | Lima | |
Peru | Teva Investigational Site 225 | Lima | |
Peru | Teva Investigational Site 226 | Lima | |
Peru | Teva Investigational Site 227 | Lima | |
Peru | Teva Investigational Site 229 | Lima | |
Philippines | Teva Investigational Site 742 | Manila | |
Philippines | Teva Investigational Site 740 | Quezon City | |
Philippines | Teva Investigational Site 741 | Quezon City | |
Philippines | Teva Investigational Site 743 | Quezon City | |
Philippines | Teva Investigational Site 745 | Quezon City | |
Poland | Teva Investigational Site 507 | Bialystok | |
Poland | Teva Investigational Site 509 | Bydgoszcz | |
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 511 | Poznan | |
Poland | Teva Investigational Site 504 | Tarnow | |
Romania | Teva Investigational Site 523 | Bucharest | |
Romania | Teva Investigational Site 524 | Bucharest | |
Romania | Teva Investigational Site 520 | Cluj-Napoca | |
Romania | Teva Investigational Site 521 | Iasi | |
Romania | Teva Investigational Site 522 | Targu Mures | |
Russian Federation | Teva Investigational Site 545 | Barnaul | |
Russian Federation | Teva Investigational Site 549 | Kemerovo | |
Russian Federation | Teva Investigational Site 543 | Moscow | |
Russian Federation | Teva Investigational Site 544 | Moscow | |
Russian Federation | Teva Investigational Site 554 | Moscow | |
Russian Federation | Teva Investigational Site 558 | Moscow | |
Russian Federation | Teva Investigational Site 559 | Moscow | |
Russian Federation | Teva Investigational Site 555 | Novosibirsk | |
Russian Federation | Teva Investigational Site 557 | Novosibirsk | |
Russian Federation | Teva Investigational Site 541 | St. Petersburg | |
Russian Federation | Teva Investigational Site 542 | St. Petersburg | |
Russian Federation | Teva Investigational Site 540 | St.Petersburg | |
Russian Federation | Teva Investigational Site 552 | Tomsk | |
Russian Federation | Teva Investigational Site 546 | Yaroslavl | |
Slovakia | Teva Investigational Site 563 | Bradejov | |
Slovakia | Teva Investigational Site 561 | Levice | |
Slovakia | Teva Investigational Site 560 | Spisska Nova Ves | |
Slovakia | Teva Investigational Site 562 | Topolcany | |
South Africa | Teva Investigational Site 584 | Cape Town | |
South Africa | Teva Investigational Site 586 | Cape Town | |
South Africa | Teva Investigational Site 587 | Centurion | |
South Africa | Teva Investigational Site 582 | Durban | |
South Africa | Teva Investigational Site 585 | Durban | |
South Africa | Teva Investigational Site 580 | Johannesburg | |
South Africa | Teva Investigational Site 589 | Johannesburg | |
South Africa | Teva Investigational Site 583 | Pretoria | |
South Africa | Teva Investigational Site 588 | Pretoria | |
Sweden | Teva Investigational Site 602 | Göteborg | |
Sweden | Teva Investigational Site 604 | Göteborg | |
Sweden | Teva Investigational Site 603 | Linköping | |
Sweden | Teva Investigational Site 600 | Lund | |
Sweden | Teva Investigational Site 601 | Malmö | |
Taiwan | Teva Investigational Site 761 | Taipei | |
Taiwan | Teva Investigational Site 763 | Taoyuan | |
Thailand | Teva Investigational Site 780 | Bangkok | |
Thailand | Teva Investigational Site 782 | Bangkok | |
Thailand | Teva Investigational Site 784 | Nakhon Ratchasima | |
Ukraine | Teva Investigational Site 621 | Dnipropetrovsk | |
Ukraine | Teva Investigational Site 629 | Donetsk | |
Ukraine | Teva Investigational Site 630 | Ivano-Frankivsk | |
Ukraine | Teva Investigational Site 620 | Kharkiv | |
Ukraine | Teva Investigational Site 633 | Kharkiv | |
Ukraine | Teva Investigational Site 622 | Kyiv | |
Ukraine | Teva Investigational Site 623 | Kyiv | |
Ukraine | Teva Investigational Site 624 | Kyiv | |
Ukraine | Teva Investigational Site 625 | Kyiv | |
Ukraine | Teva Investigational Site 626 | Vinnytsya | |
Ukraine | Teva Investigational Site 631 | Zaporizhzhia | |
Ukraine | Teva Investigational Site 632 | Zaporizhzhya | |
United States | Teva Investigational Site 66 | Altoona | Pennsylvania |
United States | Teva Investigational Site 12 | Anaheim | California |
United States | Teva Investigational Site 46 | Bangor | Maine |
United States | Teva Investigational Site 63 | Boerne | Texas |
United States | Teva Investigational Site 64 | Boys Town | Nebraska |
United States | Teva Investigational Site 21 | Charleston | South Carolina |
United States | Teva Investigational Site 20 | Cincinnati | Ohio |
United States | Teva Investigational Site 31 | Cincinnati | Ohio |
United States | Teva Investigational Site 53 | Clearwater | Florida |
United States | Teva Investigational Site 2 | Colorado Springs | Colorado |
United States | Teva Investigational Site 34 | Colorado Springs | Colorado |
United States | Teva Investigational Site 44 | Dallas | Texas |
United States | Teva Investigational Site 47 | Denver | Colorado |
United States | Teva Investigational Site 69 | El Paso | Texas |
United States | Teva Investigational Site 16 | Fort Worth | Texas |
United States | Teva Investigational Site 11 | Fountain Valley | California |
United States | Teva Investigational Site 41 | Fresno | California |
United States | Teva Investigational Site 24 | Largo | Florida |
United States | Teva Investigational Site 25 | Lawrenceville | Georgia |
United States | Teva Investigational Site 49 | Lexington | Kentucky |
United States | Teva Investigational Site 6 | Lilburn | Georgia |
United States | Teva Investigational Site 73 | Lincoln | Rhode Island |
United States | Teva Investigational Site 59 | Long Beach | California |
United States | Teva Investigational Site 43 | Los Angeles | California |
United States | Teva Investigational Site 33 | Madison | Wisconsin |
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 55 | Miami | Florida |
United States | Teva Investigational Site 32 | Nashville | Tennessee |
United States | Teva Investigational Site 50 | Oklahoma City | Oklahoma |
United States | Teva Investigational Site 8 | Omaha | Nebraska |
United States | Teva Investigational Site 4 | Orange | California |
United States | Teva Investigational Site 52 | Orlando | Florida |
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 58 | Scottsdale | Arizona |
United States | Teva Investigational Site 40 | St. Louis | Missouri |
United States | Teva Investigational Site 74 | St. Louis | Missouri |
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 |
United States | Teva Investigational Site 28 | Waterbury | Connecticut |
United States | Teva Investigational Site 30 | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Teva Branded Pharmaceutical Products, R&D Inc. |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Sweden, Taiwan, Thailand, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Summary of participants with adverse events | up to 104 weeks of treatment and a 90-day follow-up evaluation | Yes | |
Secondary | Lung function as measured by Forced Expiratory Volume in 1 second (FEV1) | 104 weeks | No | |
Secondary | Lung function as measured by percent predicted Forced Expiratory Volume in 1 second (%FEV1) | 104 weeks | No | |
Secondary | Lung function as measured by Forced Vital Capacity (FVC) | 104 weeks | No | |
Secondary | Lung function as measured by Forced Expiratory Flow at 25% to 75% FVC (FEF25-75%) | 104 weeks | No | |
Secondary | Short-acting Beta-agonist usage | 104 weeks | No | |
Secondary | Asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI) | 104 weeks | No | |
Secondary | Asthma control as measured by the Asthma Control Questionnaire (ACQ) | 104 weeks | No | |
Secondary | Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) | 116 weeks | No |
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