Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Ception Therapeutics )
ClinicalTrials.gov Identifier:
NCT00587288
First received: January 4, 2008
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.

Condition Intervention Phase
Asthma
Biological: Reslizumab
Other: Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline through End of Therapy (up to 15 weeks) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of ACQ Responders at End of Therapy [ Time Frame: Baseline, End of Therapy (up to 15 weeks) ] [ Designated as safety issue: No ]
    Responders were defined as participants achieving at least a 0.5 reduction from baseline to End of Therapy in 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.

  • Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1) [ Time Frame: Baseline, End of Therapy (up to 15 weeks) ] [ Designated as safety issue: No ]
    The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements.

  • Change From Baseline to End of Therapy in Percent Predicted FEV1 [ Time Frame: Baseline, End of Therapy (up to 15 weeks) ] [ Designated as safety issue: No ]
    The change in percent predicted FEV1 from baseline to EOT was calculated from the FEV1 measured during pulmonary function tests using standard spirometry measurements. Each participant's percent predicted FEV1 was calculated by adjusting the FEV1 for age, sex, height and race. The percent predicted FEV1 was then calculated by comparing the predicted FEV1 to the observed FEV1 using the Crapo formula (Crapo et al 1981a, Crapo and Morris 1981b, Crapo et al 1982).

  • Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels [ Time Frame: End of Screening or Baseline, End of Therapy (up to 15 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Clinical Asthma Exacerbations (CAEs) [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
    A CAE was defined as a 20% or more decrease in forced expiratory volume in 1 second (FEV1, absolute value) from the baseline value, a requirement for emergency treatment of asthma, hospital admission for asthma, or treatment with 3 or more days of oral corticosteroids for asthma worsening.

  • Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation [ Time Frame: From start of study drug through 15 weeks + 30 days ] [ Designated as safety issue: No ]
    Participants may have been included in more than 1 category. AEs summarized were those that began or worsened after dispensation of the study drug and before 30 days after the last dose of study drug. If the severity of an AE was missing, the AE was reported as "severe." If drug relationship of an AE was missing, the AE was reported as "probably related." WFT=withdrawn from treatment.


Enrollment: 106
Study Start Date: April 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reslizumab 3 mg/kg
Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Biological: Reslizumab
Other Names:
  • Cinquil™
  • CEP-38072
  • CTx55700
Placebo Comparator: Placebo
Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Other: Saline

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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-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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587288

  Hide Study Locations
Locations
United States, California
Children'S Hospital of Orange County-Pediatric Subspecialty Faculty
Orange, California, United States, 92868
United States, Colorado
Allergy & Clinical Research Center
Centennial, Colorado, United States, 80112
Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, United States, 80907
National Jewish Medical & Research Center
Denver, Colorado, United States, 80206
United States, Illinois
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States, 61761
United States, Maryland
Pulmonary Disease & Critical Care Associates, P.A.
Columbia, Maryland, United States, 21044
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Washington University of School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nebraska
The Asthma & Allergy Center
Papillion, Nebraska, United States, 68046
United States, New York
Health Sciences Research at Asthma & Allergy
Cortland, New York, United States, 13045
United States, North Carolina
Wake Forest Univeristy Health Services
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
David Bernstein
Cincinnati, Ohio, United States, 45229
Toledo Center for Clinical Research
Sylvania, Ohio, United States, 43560
United States, Oklahoma
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States, 97504
United States, Pennsylvania
Allergy and Asthma Specialists
Blue Bell, Pennsylvania, United States, 19422
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Asthma Sinus Allergy Program & Research Centers
Nashville, Tennessee, United States, 37203
United States, Virginia
Virginia Adult & Pediatric Allergy and Asthma
Richmond, Virginia, United States, 23229
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Asthma, Inc
Seatle, Washington, United States, 98105
United States, Wisconsin
Allergy, Asthma and Sinus Center
Greenfield, Wisconsin, United States, 53228
University of Wisconsin-Madison, Allergy/Asthma Clinical Research Unit
Madison, Wisconsin, United States, 53972
Canada, Alberta
Heritage Medical Research Clinic, University of Calgary
Calgary, Alberta, Canada, T2N4N1
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Queen's University, Richardson's House
Kingston, Ontario, Canada, K7L 2V6
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Hopital du Sacre-Couer de Montreal
Montreal, Quebec, Canada, H4J1C5
Canada
Hopital Laval
Quebec, Canada, G1V4G5
Sponsors and Collaborators
Ception Therapeutics
Cephalon
Investigators
Study Director: Sponsor's Medical Expert, MD Cephalon (Ception)
  More Information

Publications:
Responsible Party: Ception Therapeutics
ClinicalTrials.gov Identifier: NCT00587288     History of Changes
Other Study ID Numbers: Res-5-0010 
Study First Received: January 4, 2008
Results First Received: March 23, 2016
Last Updated: March 23, 2016
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Teva Pharmaceutical Industries:
Cinquil™
Reslizumab

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 25, 2016