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| Name | Class |
|---|---|
| Cephalon | INDUSTRY |
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The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.
Objectives:
Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation.
Secondary:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reslizumab 3 mg/kg | Experimental | Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles |
|
| Placebo | Placebo Comparator | Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reslizumab | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score | The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer. | Baseline through End of Therapy (up to 15 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ACQ Responders at End of Therapy | Responders were defined as participants achieving at least a 0.5 reduction from baseline to End of Therapy in ACQ score. The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sponsor's Medical Expert, MD | Cephalon (Ception) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children'S Hospital of Orange County-Pediatric Subspecialty Faculty | Orange | California | 92868 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21852542 | Background | Castro M, Mathur S, Hargreave F, Boulet LP, Xie F, Young J, Wilkins HJ, Henkel T, Nair P; Res-5-0010 Study Group. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2011 Nov 15;184(10):1125-32. doi: 10.1164/rccm.201103-0396OC. Epub 2011 Aug 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reslizumab 3 mg/kg | reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles |
| FG001 | Placebo | saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Saline |
| Other |
|
| Baseline, End of Therapy (up to 15 weeks) |
| Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1) | The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements. | Baseline, End of Therapy (up to 15 weeks) |
| Change From Baseline to End of Therapy in Percent Predicted FEV1 | The change in percent predicted FEV1 from baseline to End of Therapy was calculated from the FEV1 measured during pulmonary function tests using standard spirometry measurements. Each participant's percent predicted FEV1 was calculated by adjusting the FEV1 for age, sex, height and race. The percent predicted FEV1 was then calculated by comparing the predicted FEV1 to the observed FEV1 using the Crapo formula (Crapo et al 1981a, Crapo and Morris 1981b, Crapo et al 1982). | Baseline, End of Therapy (up to 15 weeks) |
| Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels | End of Screening or Baseline, End of Therapy (up to 15 weeks) |
| Percentage of Participants With Clinical Asthma Exacerbations (CAEs) | A CAE was defined as a 20% or more decrease in forced expiratory volume in 1 second (FEV1, absolute value) from the baseline value, a requirement for emergency treatment of asthma, hospital admission for asthma, or treatment with 3 or more days of oral corticosteroids for asthma worsening. | up to 15 weeks |
| Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Participants may have been included in more than 1 category. AEs summarized were those that began or worsened after dispensation of the study drug and before 30 days after the last dose of study drug. If the severity of an AE was missing, the AE was reported as "severe." If drug relationship of an AE was missing, the AE was reported as "probably related." WFT=withdrawn from treatment. | From start of study drug through 15 weeks + 30 days |
| Allergy & Clinical Research Center |
| Centennial |
| Colorado |
| 80112 |
| United States |
| Asthma & Allergy Associates, P.C. | Colorado Springs | Colorado | 80907 | United States |
| National Jewish Medical & Research Center | Denver | Colorado | 80206 | United States |
| Sneeze, Wheeze & Itch Associates, LLC | Normal | Illinois | 61761 | United States |
| Pulmonary Disease & Critical Care Associates, P.A. | Columbia | Maryland | 21044 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| Washington University of School of Medicine | St Louis | Missouri | 63110 | United States |
| The Asthma & Allergy Center | Papillion | Nebraska | 68046 | United States |
| Health Sciences Research at Asthma & Allergy | Cortland | New York | 13045 | United States |
| Wake Forest Univeristy Health Services | Winston-Salem | North Carolina | 27157 | United States |
| David Bernstein | Cincinnati | Ohio | 45229 | United States |
| Toledo Center for Clinical Research | Sylvania | Ohio | 43560 | United States |
| Allergy, Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Clinical Research Institute of Southern Oregon | Medford | Oregon | 97504 | United States |
| Allergy and Asthma Specialists | Blue Bell | Pennsylvania | 19422 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt Asthma Sinus Allergy Program & Research Centers | Nashville | Tennessee | 37203 | United States |
| Virginia Adult & Pediatric Allergy and Asthma | Richmond | Virginia | 23229 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Asthma, Inc | Seatle | Washington | 98105 | United States |
| Allergy, Asthma and Sinus Center | Greenfield | Wisconsin | 53228 | United States |
| University of Wisconsin-Madison, Allergy/Asthma Clinical Research Unit | Madison | Wisconsin | 53972 | United States |
| Heritage Medical Research Clinic, University of Calgary | Calgary | Alberta | T2N4N1 | Canada |
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| Queen's University, Richardson's House | Kingston | Ontario | K7L 2V6 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Hopital du Sacre-Couer de Montreal | Montreal | Quebec | H4J1C5 | Canada |
| Hopital Laval | Québec | Quebec | G1V4G5 | Canada |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reslizumab 3 mg/kg | reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles |
| BG001 | Placebo | saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score | The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer. | Intent-to-treat (ITT) Analysis Set: all participants who received any amount of randomly assigned study drug. | Posted | Mean | Standard Deviation | units on a scale | Baseline through End of Therapy (up to 15 weeks) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of ACQ Responders at End of Therapy | Responders were defined as participants achieving at least a 0.5 reduction from baseline to End of Therapy in ACQ score. The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer. | ITT Analysis Set: all participants who received any amount of randomly assigned study drug. | Posted | Number | percentage of participants | Baseline, End of Therapy (up to 15 weeks) |
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| Secondary | Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1) | The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements. | ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy. | Posted | Mean | Standard Deviation | L | Baseline, End of Therapy (up to 15 weeks) |
|
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| Secondary | Change From Baseline to End of Therapy in Percent Predicted FEV1 | The change in percent predicted FEV1 from baseline to End of Therapy was calculated from the FEV1 measured during pulmonary function tests using standard spirometry measurements. Each participant's percent predicted FEV1 was calculated by adjusting the FEV1 for age, sex, height and race. The percent predicted FEV1 was then calculated by comparing the predicted FEV1 to the observed FEV1 using the Crapo formula (Crapo et al 1981a, Crapo and Morris 1981b, Crapo et al 1982). | ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy. | Posted | Mean | Standard Deviation | percent predicted FEV1 | Baseline, End of Therapy (up to 15 weeks) |
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| Secondary | Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels | ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy. | Posted | Mean | Standard Deviation | percent change in eosinophil levels | End of Screening or Baseline, End of Therapy (up to 15 weeks) |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Asthma Exacerbations (CAEs) | A CAE was defined as a 20% or more decrease in forced expiratory volume in 1 second (FEV1, absolute value) from the baseline value, a requirement for emergency treatment of asthma, hospital admission for asthma, or treatment with 3 or more days of oral corticosteroids for asthma worsening. | ITT Analysis Set: all participants who received any amount of randomly assigned study drug. | Posted | Number | percentage of participants | up to 15 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Participants may have been included in more than 1 category. AEs summarized were those that began or worsened after dispensation of the study drug and before 30 days after the last dose of study drug. If the severity of an AE was missing, the AE was reported as "severe." If drug relationship of an AE was missing, the AE was reported as "probably related." WFT=withdrawn from treatment. | ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy. | Posted | Number | participants | From start of study drug through 15 weeks + 30 days |
|
|
From start of study drug through 15 weeks + 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reslizumab 3 mg/kg | reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles | 2 | 53 | 17 | 53 | ||
| EG001 | Placebo | saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles | 1 | 53 | 17 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PNEUMONIA | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FATIGUE | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 215-591-3000 | ustevatrials@tevapharm.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C515492 | reslizumab |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| 45 to < 65 years |
|
| >/= 65 years |
|
| Male |
|
| Units | Counts |
|---|
| Participants |
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