Clinical Trial: Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma

Brief Summary: The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).

Detailed Summary:
Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.

Current Primary Outcome: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set [ Time Frame: Baseline (Day 1), Week 16 ]

FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.

Data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group.



Original Primary Outcome: Change in Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Baseline and Week 16 ]

FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.


Current Secondary Outcome:

  • Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, 16 ]

    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.

    During study (Weeks 4, 8, 12 and 16) average value was calculated using a mixed effects model for repeated measures (MMRM) with treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as a random effect.

  • Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, 16 ]

    The ACQ score was measured using the ACQ-7. Six questions are-self assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.

    During study (Weeks 4, 8, 12 and 16) average value was calculated from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, history of asthma exacerbation in the previous year, height, baseline value, and sex as fixed factors, and patient as a random effect.

  • Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation [ Time Frame: Baseline (Day 1), Week 16 ]

    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.

    As with the primary outcome, data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group. However the FEV1 subpopulation includes participants with more impaired lung function (% predicted FEV1 <85% at baseline).

  • Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16 [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, and 16 ]
    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
  • Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, and 16 ]
    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva. Positive change from baseline scores indicate improvement in asthma control.
  • Change From Baseline in Forced Vital Capacity (FVC) at Weeks 4, 8, 12, and 16 [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, and 16 ]
    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. FV was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
  • Change From Baseline in the Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) at Weeks 4, 8, 12, and 16 [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, and 16 ]
    The FEF25%-75% is the forced expiratory flow at 25% to 75% of the forced vital capacity. FEF25%-75% was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
  • Change From Baseline in Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) at Weeks 4, 8, 12, and 16 [ Time Frame: Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16 ]
    SABA are used for quick relief of asthma symptoms. The number of times SABA therapy was used

    Original Secondary Outcome:

    • Change in FEV1 [ Time Frame: Baseline and Week 4 ]
      FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
    • Change in FEV1 [ Time Frame: Baseline and Week 8 ]
      FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
    • Change in FEV1 [ Time Frame: Baseline and Week 12 ]
      FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
    • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 4 ]
      The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the forced vital capacity (FVC).
    • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 8 ]
      The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the FVC.
    • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 12 ]
      The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the FVC.
    • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 16 ]
      The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the FVC.
    • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 4 ]
      The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
    • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 8 ]
      The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
    • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 12 ]
      The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
    • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 16 ]
      The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
    • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 4 ]
      FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
    • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 8 ]
      FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
    • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 12 ]
      FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
    • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 16 ]
      FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
    • Change in Beta-agonist use [ Time Frame: Baseline and Week 4 ]
      The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist therapy, name of medicine, and number of puffs inhaled.
    • Change in Beta-agonist use [ Time Frame: Baseline and Week 8 ]
      The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist thera

      Information By: Teva Pharmaceutical Industries

      Dates:
      Date Received: January 3, 2012
      Date Started: February 2012
      Date Completion:
      Last Updated: May 26, 2016
      Last Verified: May 2016