Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.

Key facts

Study ID

NCT00587288

Run by

Ception Therapeutics

People needed

106

Starts

2008-04-01

Expected to finish

2010-03-01

Last updated by the study team

2016-08-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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).
• current suspected drug and/or alcohol abuse

Where it is running

• 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

Full record on ClinicalTrials.gov

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