- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01285323
A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma
A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ciudad Autonoma de Buenos Aire, Argentina
- Teva Investigational Site 121
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Ciudad Autonoma de Buenos Aire, Argentina
- Teva Investigational Site 126
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Rosario-Santa Fe, Argentina
- Teva Investigational Site 123
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San Miguel De Tucuman - Tucuma, Argentina
- Teva Investigational Site 120
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Florianopolis, Brazil
- Teva Investigational Site 150
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Porto Alegre, Brazil
- Teva Investigational Site 140
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Porto Alegre, Brazil
- Teva Investigational Site 144
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Porto Alegre, Brazil
- Teva Investigational Site 145
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Porto Alegre, RS, Brazil
- Teva Investigational Site 143
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Santo André, São Paulo, Brazil
- Teva Investigational Site 142
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Newmarket, Canada
- Teva Investigational Site 104
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Pointe-Claire, Canada
- Teva Investigational Site 102
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Windsor, Canada
- Teva Investigational Site 105
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Grenoble, France
- Teva Investigational Site 343
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Marseille, France
- Teva Investigational Site 342
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Montpellier, France
- Teva Investigational Site 341
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Bad Wörishofen, Germany
- Teva Investigational Site 360
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Berlin, Germany
- Teva Investigational Site 361
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Berlin, Germany
- Teva Investigational Site 362
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Berlin, Germany
- Teva Investigational Site 366
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Bochum, Germany
- Teva Investigational Site 371
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Dresden, Germany
- Teva Investigational Site 365
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Frankfurt, Germany
- Teva Investigational Site 369
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Hamburg, Germany
- Teva Investigational Site 370
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Koblenz, Germany
- Teva Investigational Site 372
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Leipzig, Germany
- Teva Investigational Site 367
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Leipzig, Germany
- Teva Investigational Site 368
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Mainz, Germany
- Teva Investigational Site 363
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Mainz, Germany
- Teva Investigational Site 364
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Alexandroupolis, Greece
- Teva Investigational Site 381
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Athens, Greece
- Teva Investigational Site 380
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Heraklion, Crete, Greece
- Teva Investigational Site 382
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Gwangju, Korea, Republic of
- Teva Investigational Site 682
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Seoul, Korea, Republic of
- Teva Investigational Site 680
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Seoul, Korea, Republic of
- Teva Investigational Site 681
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Seoul, Korea, Republic of
- Teva Investigational Site 683
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Seoul, Korea, Republic of
- Teva Investigational Site 686
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Suwon, Korea, Republic of
- Teva Investigational Site 685
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Ciudad De México, Mexico
- Teva Investigational Site 205
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Distrito Federal, Mexico
- Teva Investigational Site 203
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Guadalajara, JAL, Mexico
- Teva Investigational Site 204
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Mexico City, Mexico
- Teva Investigational Site 207
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Monterrey, Mexico
- Teva Investigational Site 209
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Tijuana, B.C., Mexico
- Teva Investigational Site 202
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Cercado De Lima, Lima, Peru
- Teva Investigational Site 223
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Lima, Peru
- Teva Investigational Site 220
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Lima, Peru
- Teva Investigational Site 221
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Lima, Peru
- Teva Investigational Site 222
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Lima, Peru
- Teva Investigational Site 225
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Lima, Peru
- Teva Investigational Site 226
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Lima, Peru
- Teva Investigational Site 227
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Lima, Peru
- Teva Investigational Site 229
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Bucharest, Romania
- Teva Investigational Site 523
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Bucharest, Romania
- Teva Investigational Site 524
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Cluj-Napoca, Romania
- Teva Investigational Site 520
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Iasi, Romania
- Teva Investigational Site 521
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Targu Mures, Romania
- Teva Investigational Site 522
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Moscow, Russian Federation
- Teva Investigational Site 543
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Moscow, Russian Federation
- Teva Investigational Site 544
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Moscow, Russian Federation
- Teva Investigational Site 554
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Moscow, Russian Federation
- Teva Investigational Site 556
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Moscow, Russian Federation
- Teva Investigational Site 558
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Moscow, Russian Federation
- Teva Investigational Site 559
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Novosibirsk, Russian Federation
- Teva Investigational Site 557
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St. Petersburg, Russian Federation
- Teva Investigational Site 541
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St.Petersburg, Russian Federation
- Teva Investigational Site 540
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Bradejov, Slovakia
- Teva Investigational Site 563
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Levice, Slovakia
- Teva Investigational Site 561
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Spisska Nova Ves, Slovakia
- Teva Investigational Site 560
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Topolcany, Slovakia
- Teva Investigational Site 562
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Kaohsiung, Taiwan
- Teva Investigational Site 764
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Taichung, Taiwan
- Teva Investigational Site 765
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Taipei, Taiwan
- Teva Investigational Site 760
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Taipei, Taiwan
- Teva Investigational Site 761
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Taoyuan, Taiwan
- Teva Investigational Site 763
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Dnipropetrovsk, Ukraine
- Teva Investigational Site 621
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Donetsk, Ukraine
- Teva Investigational Site 629
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Donetsk, Ukraine
- Teva Investigational Site 635
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Ivano-Frankivsk, Ukraine
- Teva Investigational Site 630
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Kharkiv, Ukraine
- Teva Investigational Site 620
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Kharkiv, Ukraine
- Teva Investigational Site 633
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Kyiv, Ukraine
- Teva Investigational Site 622
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Kyiv, Ukraine
- Teva Investigational Site 623
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Kyiv, Ukraine
- Teva Investigational Site 624
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Kyiv, Ukraine
- Teva Investigational Site 625
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Ternopil, Ukraine
- Teva Investigational Site 628
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Vinnytsya, Ukraine
- Teva Investigational Site 626
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Zaporizhzhia, Ukraine
- Teva Investigational Site 631
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Zaporizhzhia, Ukraine
- Teva Investigational Site 632
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Alabama
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Mobile, Alabama, United States
- Teva Investigational Site 48
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California
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Fresno, California, United States
- Teva Investigational Site 41
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Long Beach, California, United States
- Teva Investigational Site 59
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Colorado
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Denver, Colorado, United States
- Teva Investigational Site 47
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Connecticut
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Waterbury, Connecticut, United States
- Teva Investigational Site 28
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Florida
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Clearwater, Florida, United States
- Teva Investigational Site 53
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Miami, Florida, United States
- Teva Investigational Site 27
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Georgia
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Lawrenceville, Georgia, United States
- Teva Investigational Site 25
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Louisiana
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Metairie, Louisiana, United States
- Teva Investigational Site 57
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Maine
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Bangor, Maine, United States
- Teva Investigational Site 46
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Missouri
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Saint Louis, Missouri, United States
- Teva Investigational Site 40
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South Carolina
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Fort Mill, South Carolina, United States
- Teva Investigational Site 67
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Texas
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Dallas, Texas, United States
- Teva Investigational Site 44
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El Paso, Texas, United States
- Teva Investigational Site 69
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San Antonio, Texas, United States
- Teva Investigational Site 45
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Germany, India, Argentina, and Korea; patients 66 through 75 years of age are excluded from participating in India and Korea.
- The patient has had at least 1 asthma exacerbation requiring oral, intramuscular (im), or intravenous (iv) corticosteroid use for at least 3 days over the past 12 months before screening.
- The patient has a current blood eosinophil level of at least 400/μL.
- The patient has airway reversibility of at least 12% to beta-agonist administration.
- The patient has an ACQ score of at least 1.5 5 at the screening and baseline (before the 1st dose of study drug) visits.
- 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.
- All female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) 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. 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.
- Written informed consent is obtained. Patients 12 through 17 years old, where participating, must provide assent.
- 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.
- 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.
- 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.
Exclusion Criteria:
- The patient has a clinically meaningful co-morbidity 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). Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) will also be excluded.
- The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
- The patient is using systemic immunosuppressive, immunomodulating, or other biologic agents (including, but not limited to, anti-immunoglobulin E (IgE) mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor [anti-TNF] mAb) within 6 months prior to screening.
- The patient has previously received an anti-hIL-5 monoclonal antibody (eg, reslizumab, mepolizumab, or benralizumab).
- The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).
- 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 6 months prior to screening.
- Other exclusion criteria apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
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Matching placebo (acetate sucrose buffer), administered intravenously (iv) once every 4 weeks for a total of 13 doses.
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Experimental: Reslizumab 3.0 mg/kg
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
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Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment
Time Frame: Day 1 to Month 12
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An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:
CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are offered as adjusted means. |
Day 1 to Month 12
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Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)
Time Frame: Day 1 to Month 12
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An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:
Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors. Results are offered as adjusted means. |
Day 1 to Month 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16
Time Frame: Day 1 (baseline, pre-dose), Week 16
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The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were "patient-specific," which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits. Positive change from baseline scores indicate improvement in quality of life. |
Day 1 (baseline, pre-dose), Week 16
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Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures
Time Frame: Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
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The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Negative change from baseline scores indicate improvement in asthma control. |
Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
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Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures
Time Frame: Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
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The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms. The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms. |
Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
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Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) At Week 16
Time Frame: Day 1 (baseline, pre-dose), Week 16
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FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. Positive change from baseline scores indicate improvement in asthma control. |
Day 1 (baseline, pre-dose), Week 16
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Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures
Time Frame: Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16
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FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. During study (Weeks 4, 8, 12 and 16) average value used a mixed effect model for repeated measures (MMRM) with treatment group, visit, treatment and visit interaction, and stratification factors as fixed effects and participant as a random effect. Covariates for baseline values were also included in the model; for pulmonary function test analyses, covariates for height and sex were included as well. Positive change from baseline scores indicate improvement in asthma control. |
Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16
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Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)
Time Frame: Day 1 to Day 526 (longest treatment time plus 2 weeks)
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An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:
CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other). |
Day 1 to Day 526 (longest treatment time plus 2 weeks)
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Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures
Time Frame: Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
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SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3. The during treatment (Weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Negative change from baseline scores indicate improvement in asthma control. |
Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
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Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures
Time Frame: Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal
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The blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test. Results of all differential blood tests conducted after randomization were blinded. The during treatment average eosinophil count was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. The 'over 16 weeks' value used data from Weeks 4, 8, 12 and 16. The 'over 52 weeks' value used all the during study time points listed in the Time Frame field. Negative change from baseline values correlate to reduced asthma severity. |
Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal
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Participants With Treatment-Emergent Adverse Events TEAE)
Time Frame: Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
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An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug.
Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities.
Relation of AE to treatment was determined by the investigator.
Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
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Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
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Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values
Time Frame: Week 4 to Week 52
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Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values. Significance criteria:
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Week 4 to Week 52
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Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values
Time Frame: Week 4 to Week 52
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Data represents participants with potentially clinically significant (PCS) vital sign values. Significance criteria
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Week 4 to Week 52
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Participants With a Positive Anti-Reslizumab Antibody Status During Study
Time Frame: Baseline visit (prior to reslizumab exposure), Weeks 16, 32, 48 and 52
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Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm.
Blood samples were collected for determination of ADAs before study drug infusion.
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Baseline visit (prior to reslizumab exposure), Weeks 16, 32, 48 and 52
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Collaborators and Investigators
Investigators
- Study Director: Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.
Publications and helpful links
General Publications
- Nair P, Bardin P, Humbert M, Murphy KR, Hickey L, Garin M, Vanlandingham R, Chanez P. Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):555-564. doi: 10.1016/j.jaip.2019.09.036. Epub 2019 Oct 15.
- Carr WW, McDonald M, Meizlik P. Effect of intravenously administered reslizumab on spirometric lung age in patients with moderate-to-severe eosinophilic asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):240-249. doi: 10.2500/aap.2019.40.4225.
- Han S, Kim S, Kim H, Suh HS. Cost-utility analysis of reslizumab for patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and long-acting beta2-agonists in South Korea. Curr Med Res Opin. 2019 Sep;35(9):1597-1605. doi: 10.1080/03007995.2019.1605159. Epub 2019 May 16.
- Bateman ED, Djukanovic R, Castro M, Canvin J, Germinaro M, Noble R, Garin M, Buhl R. Predicting Responders to Reslizumab after 16 Weeks of Treatment Using an Algorithm Derived from Clinical Studies of Patients with Severe Eosinophilic Asthma. Am J Respir Crit Care Med. 2019 Feb 15;199(4):489-495. doi: 10.1164/rccm.201708-1668OC.
- Weinstein SF, Katial RK, Bardin P, Korn S, McDonald M, Garin M, Bateman ED, Hoyte FCL, Germinaro M. Effects of Reslizumab on Asthma Outcomes in a Subgroup of Eosinophilic Asthma Patients with Self-Reported Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2019 Feb;7(2):589-596.e3. doi: 10.1016/j.jaip.2018.08.021. Epub 2018 Sep 5.
- Brusselle G, Germinaro M, Weiss S, Zangrilli J. Reslizumab in patients with inadequately controlled late-onset asthma and elevated blood eosinophils. Pulm Pharmacol Ther. 2017 Apr;43:39-45. doi: 10.1016/j.pupt.2017.01.011. Epub 2017 Jan 31.
- Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, Murphy K, Maspero JF, O'Brien C, Korn S. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015 May;3(5):355-66. doi: 10.1016/S2213-2600(15)00042-9. Epub 2015 Feb 23. Erratum In: Lancet Respir Med. 2015 Apr;3(4):e15. Lancet Respir Med. 2016 Oct;4(10 ):e50.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Hematologic Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Leukocyte Disorders
- Eosinophilia
- Hypereosinophilic Syndrome
- Asthma
- Pulmonary Eosinophilia
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reslizumab
Other Study ID Numbers
- C38072/3083
- 2010-024006-35 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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National Jewish HealthTeva Pharmaceuticals USAUnknown
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