Clinical trial NCT00587288: Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
Official title: An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Cinquil™
Reslizumab
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cephalon
First posted: 2008-01-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Objectives:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score
timeFrame: Baseline through End of Therapy (up to 15 weeks)
Secondary outcomes:
measure: Percentage of ACQ Responders at End of Therapy
timeFrame: Baseline, End of Therapy (up to 15 weeks)
measure: Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)
timeFrame: Baseline, End of Therapy (up to 15 weeks)
measure: Change From Baseline to End of Therapy in Percent Predicted FEV1
timeFrame: Baseline, End of Therapy (up to 15 weeks)
measure: Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels
timeFrame: End of Screening or Baseline, End of Therapy (up to 15 weeks)
measure: Percentage of Participants With Clinical Asthma Exacerbations (CAEs)
timeFrame: up to 15 weeks
measure: Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation
timeFrame: From start of study drug through 15 weeks + 30 days
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children'S Hospital of Orange County-Pediatric Subspecialty Faculty
state: California
city: Centennial
country: United States
facility: Allergy & Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma & Allergy Associates, P.C.
state: Colorado
city: Denver
country: United States
facility: National Jewish Medical & Research Center
state: Colorado
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, LLC
state: Illinois
city: Columbia
country: United States
facility: Pulmonary Disease & Critical Care Associates, P.A.
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: St. Louis
country: United States
facility: Washington University of School of Medicine
state: Missouri
city: Papillion
country: United States
facility: The Asthma & Allergy Center
state: Nebraska
city: Cortland
country: United States
facility: Health Sciences Research at Asthma & Allergy
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Univeristy Health Services
state: North Carolina
city: Cincinnati
country: United States
facility: David Bernstein
state: Ohio
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon
state: Oregon
city: Blue Bell
country: United States
facility: Allergy and Asthma Specialists
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Asthma Sinus Allergy Program & Research Centers
state: Tennessee
city: Richmond
country: United States
facility: Virginia Adult & Pediatric Allergy and Asthma
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seatle
country: United States
facility: Asthma, Inc
state: Washington
city: Greenfield
country: United States
facility: Allergy, Asthma and Sinus Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin-Madison, Allergy/Asthma Clinical Research Unit
state: Wisconsin
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic, University of Calgary
state: Alberta
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Kingston
country: Canada
facility: Queen's University, Richardson's House
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital du Sacre-Couer de Montreal
state: Quebec
city: Quebec
country: Canada
facility: Hopital Laval
Study officials:
affiliation: Cephalon (Ception)
name: Sponsor's Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.