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: August 16, 2013
Last verified: August 2013
  Purpose

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.


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:
  • Asthma Control Questionnaire [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Forced expiratory volume in the first second [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Number of asthma exacerbations [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Eosinophil levels [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: November 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Reslizumab 3 mg/kg
Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 day cycle (+/- 7 days) Number of Cycles=4
Other Name: Cinquil™
Placebo Comparator: 2
Saline
Other: Saline
IV (in the vein) on Day 0 of each 28 day cycle (+/-7 days) Number of Cycles=4

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 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
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, 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
  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

  Show 30 Study Locations
Sponsors and Collaborators
Ception Therapeutics
Cephalon
Investigators
Study Director: Sponsor's Medical Expert, MD Cephalon (Ception)
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Ception Therapeutics )
ClinicalTrials.gov Identifier: NCT00587288     History of Changes
Other Study ID Numbers: Res-5-0010
Study First Received: January 4, 2008
Last Updated: August 16, 2013
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 26, 2014