Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation
1 other identifier
interventional
106
2 countries
30
Brief Summary
The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Apr 2008
Typical duration for phase_2 asthma
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 7, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
April 26, 2016
CompletedAugust 17, 2016
July 1, 2016
1.9 years
January 4, 2008
March 23, 2016
July 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (6)
Percentage of ACQ Responders at End of Therapy
Baseline, End of Therapy (up to 15 weeks)
Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)
Baseline, End of Therapy (up to 15 weeks)
Change From Baseline to End of Therapy in Percent Predicted FEV1
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)
up to 15 weeks
- +1 more secondary outcomes
Study Arms (2)
Reslizumab 3 mg/kg
EXPERIMENTALReslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Placebo
PLACEBO COMPARATORSaline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Interventions
Eligibility Criteria
You may qualify if:
- written informed consent
- 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
You may not qualify if:
- a clinically important event that would interfere with study schedule or procedure or compromise subject safety
- 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).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ception Therapeuticslead
- Cephaloncollaborator
Study Sites (30)
Children'S Hospital of Orange County-Pediatric Subspecialty Faculty
Orange, California, 92868, United States
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
Related Publications (1)
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.
PMID: 21852542BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Study Officials
- STUDY DIRECTOR
Sponsor's Medical Expert, MD
Cephalon (Ception)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 7, 2008
Study Start
April 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
August 17, 2016
Results First Posted
April 26, 2016
Record last verified: 2016-07