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Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

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ClinicalTrials.gov Identifier: NCT00587288
Recruitment Status : Completed
First Posted : January 7, 2008
Results First Posted : April 26, 2016
Last Update Posted : August 17, 2016
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Ception Therapeutics )

Brief Summary:
The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.

Condition or disease Intervention/treatment Phase
Asthma Biological: Reslizumab Other: Saline Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2008
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Reslizumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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) ]
    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 :
  1. Percentage of ACQ Responders at End of Therapy [ Time Frame: Baseline, End of Therapy (up to 15 weeks) ]
    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.

  2. 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) ]
    The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements.

  3. Change From Baseline to End of Therapy in Percent Predicted FEV1 [ Time Frame: Baseline, End of Therapy (up to 15 weeks) ]
    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).

  4. 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) ]
  5. Percentage of Participants With Clinical Asthma Exacerbations (CAEs) [ Time Frame: up to 15 weeks ]
    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.

  6. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587288


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

Publications:
Responsible Party: Ception Therapeutics
ClinicalTrials.gov Identifier: NCT00587288     History of Changes
Other Study ID Numbers: Res-5-0010
First Posted: January 7, 2008    Key Record Dates
Results First Posted: April 26, 2016
Last Update Posted: August 17, 2016
Last Verified: July 2016

Keywords provided by Teva Pharmaceutical Industries ( Ception Therapeutics ):
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
Reslizumab
Anti-Asthmatic Agents
Respiratory System Agents