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: July 18, 2016
Last verified: July 2016

January 4, 2008
July 18, 2016
April 2008
March 2010   (final data collection date for primary outcome measure)
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.
Asthma Control Questionnaire [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00587288 on ClinicalTrials.gov Archive Site
  • 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 End of Therapy 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.
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation
The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Biological: Reslizumab
    Other Names:
    • Cinquil™
    • CEP-38072
    • CTx55700
  • Other: Saline
  • Experimental: Reslizumab 3 mg/kg
    Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
    Intervention: Biological: Reslizumab
  • Placebo Comparator: Placebo
    Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
    Intervention: Other: Saline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00587288
Res-5-0010
Yes
Not Provided
Not Provided
Ception Therapeutics
Ception Therapeutics
Cephalon
Study Director: Sponsor's Medical Expert, MD Cephalon (Ception)
Teva Pharmaceutical Industries
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP