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

  Show 30 Study Locations
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 21, 2016