Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

Asthma Clinical Trial

Official title:

An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587288
• Other study ID #: Res-5-0010
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2008
• Last updated: August 16, 2013
• Start date: November 2007
• Est. completion date: March 2010

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review CommitteeUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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, 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 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-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Reslizumab
IV (in the vein) on Day 0 of each 28 day cycle (+/- 7 days) Number of Cycles=4

Other:
• Saline
IV (in the vein) on Day 0 of each 28 day cycle (+/-7 days) Number of Cycles=4

Locations

Country	Name	City	State
Canada	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	Hopital du Sacre-Couer de Montreal	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Hopital Laval	Quebec
United States	Allergy and Asthma Specialists	Blue Bell	Pennsylvania
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Allergy & Clinical Research Center	Centennial	Colorado
United States	David Bernstein	Cincinnati	Ohio
United States	Asthma & Allergy Associates, P.C.	Colorado Springs	Colorado
United States	Pulmonary Disease & Critical Care Associates, P.A.	Columbia	Maryland
United States	Health Sciences Research at Asthma & Allergy	Cortland	New York
United States	National Jewish Medical & Research Center	Denver	Colorado
United States	Allergy, Asthma and Sinus Center	Greenfield	Wisconsin
United States	University of Wisconsin-Madison, Allergy/Asthma Clinical Research Unit	Madison	Wisconsin
United States	Clinical Research Institute of Southern Oregon	Medford	Oregon
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Vanderbilt Asthma Sinus Allergy Program & Research Centers	Nashville	Tennessee
United States	Sneeze, Wheeze & Itch Associates, LLC	Normal	Illinois
United States	Allergy, Asthma and Clinical Research Center	Oklahoma City	Oklahoma
United States	Children'S Hospital of Orange County-Pediatric Subspecialty Faculty	Orange	California
United States	The Asthma & Allergy Center	Papillion	Nebraska
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
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	Washington University of School of Medicine	St. Louis	Missouri
United States	Toledo Center for Clinical Research	Sylvania	Ohio
United States	Wake Forest Univeristy Health Services	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Ception Therapeutics	Cephalon

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire		15 weeks	No
Secondary	Forced expiratory volume in the first second		15 weeks	No
Secondary	Number of asthma exacerbations		15 weeks	No
Secondary	Eosinophil levels		15 weeks	No