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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (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.
Time frame: Baseline through End of Therapy (up to 15 weeks)
Percentage of ACQ Responders at End of Therapy
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.
Time frame: Baseline, End of Therapy (up to 15 weeks)
Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)
The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements.
Time frame: Baseline, End of Therapy (up to 15 weeks)
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Children'S Hospital of Orange County-Pediatric Subspecialty Faculty
Orange, California, United States
Allergy & Clinical Research Center
Centennial, Colorado, United States
Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, United States
National Jewish Medical & Research Center
Denver, Colorado, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States
Pulmonary Disease & Critical Care Associates, P.A.
Columbia, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Washington University of School of Medicine
St Louis, Missouri, United States
The Asthma & Allergy Center
Papillion, Nebraska, United States
...and 20 more locations
Change From Baseline to End of Therapy in Percent Predicted FEV1
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).
Time frame: Baseline, End of Therapy (up to 15 weeks)
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)
Percentage of Participants With Clinical Asthma Exacerbations (CAEs)
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.
Time frame: up to 15 weeks
Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation
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.
Time frame: From start of study drug through 15 weeks + 30 days