Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
NCT ID: NCT00587288
Last Updated: 2016-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2008-04-30
2010-03-31
Brief Summary
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Detailed Description
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Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation.
Secondary:
* To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in subjects with asthma.
* To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in forced expiratory volume in 1 second (FEV1; absolute value) from the baseline value or a requirement for emergency treatment of asthma, hospital admission for asthma or treatment with three or more days of oral corticosteroids (OCS) for asthma worsening.
* To assess the safety and tolerability of reslizumab in subjects with asthma.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Reslizumab 3 mg/kg
Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Reslizumab
Placebo
Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Saline
Interventions
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Reslizumab
Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* male or female subjects aged ≥ 18 to 75 years at time of screening
* female if she is of non-childbearing potential, or of childbearing potential and willing to use specific barrier methods specified in protocol
* confirmation of asthma
* symptoms consistent with a diagnosis of asthma that is poorly controlled with an inhaled corticosteroid as determined by an Asthma Control Questionnaire (ACQ) score ≥ 1.5
* requirement for treatment with high dose daily fluticasone and at least one other agent for the treatment of asthma not specifically excluded in the protocol
* requirement for \>/= 3% eosinophils in induced sputum at Screening
Exclusion Criteria
* a diagnosis of hypereosinophilic syndrome
* an underlying lung disorder
* a current smoker
* use of systemic immunosuppressive agents within 6 months of study
* current use of systemic corticosteroids
* received attenuated live attenuated vaccines within three months prior to study entry
* expected to be poorly compliant with study drug, procedures, visits
* aggravating factors that are inadequately controlled
* participation in any investigational drug or device study within 30 days prior to study entry
* participation in biologics study within 3 months prior to study entry
* receipt of anti-human interleukin-5 (hIL-5) antibody within 6 months of study entry
* female subjects who are pregnant or nursing
* concurrent infection or disease that may preclude assessment of eosinophilic esophagitis
* concurrent immunodeficiency (human immunodeficiency \[HIV\], or acquired immunodeficiency syndrome \[AIDS\] or congenital immunodeficiency).
* current suspected drug and/or alcohol abuse
18 Years
75 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Ception Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Sponsor's Medical Expert, MD
Role: STUDY_DIRECTOR
Cephalon (Ception)
Locations
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Children'S Hospital of Orange County-Pediatric Subspecialty Faculty
Orange, California, United States
Allergy & Clinical Research Center
Centennial, Colorado, United States
Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, United States
National Jewish Medical & Research Center
Denver, Colorado, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States
Pulmonary Disease & Critical Care Associates, P.A.
Columbia, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Washington University of School of Medicine
St Louis, Missouri, United States
The Asthma & Allergy Center
Papillion, Nebraska, United States
Health Sciences Research at Asthma & Allergy
Cortland, New York, United States
Wake Forest Univeristy Health Services
Winston-Salem, North Carolina, United States
David Bernstein
Cincinnati, Ohio, United States
Toledo Center for Clinical Research
Sylvania, Ohio, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States
Allergy and Asthma Specialists
Blue Bell, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Asthma Sinus Allergy Program & Research Centers
Nashville, Tennessee, United States
Virginia Adult & Pediatric Allergy and Asthma
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Asthma, Inc
Seatle, Washington, United States
Allergy, Asthma and Sinus Center
Greenfield, Wisconsin, United States
University of Wisconsin-Madison, Allergy/Asthma Clinical Research Unit
Madison, Wisconsin, United States
Heritage Medical Research Clinic, University of Calgary
Calgary, Alberta, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Queen's University, Richardson's House
Kingston, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Hopital du Sacre-Couer de Montreal
Montreal, Quebec, Canada
Hopital Laval
Québec, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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Res-5-0010
Identifier Type: -
Identifier Source: org_study_id
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