Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

Phase 2

Completed

Conditions: Asthma

Interventions: Other: Saline
Biological: Reslizumab

Registration Number: NCT00587288

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 106

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Reslizumab 3 mg/kg	Reslizumab	Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score	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

Name	Time	Method
Change From Baseline to End of Therapy in Percent Predicted FEV1	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).
Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels	End of Screening or Baseline, End of Therapy (up to 15 weeks)
Percentage of Participants With Clinical Asthma Exacerbations (CAEs)	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.
Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation	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.
Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)	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.
Percentage of ACQ Responders at End of Therapy	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.

Trial Locations

Locations (30): Washington University of School of Medicine
🇺🇸
St. Louis, Missouri, United States
Allergy & Clinical Research Center
🇺🇸
Centennial, Colorado, United States
Children'S Hospital of Orange County-Pediatric Subspecialty Faculty
🇺🇸
Orange, California, 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
Health Sciences Research at Asthma & Allergy
🇺🇸
Cortland, New York, United States
David Bernstein
🇺🇸
Cincinnati, Ohio, United States
Wake Forest Univeristy Health Services
🇺🇸
Winston-Salem, North Carolina, United States
Allergy and Asthma Specialists
🇺🇸
Blue Bell, Pennsylvania, United States
Toledo Center for Clinical Research
🇺🇸
Sylvania, Ohio, United States
Clinical Research Institute of Southern Oregon
🇺🇸
Medford, Oregon, United States
Allergy, Asthma and Clinical Research Center
🇺🇸
Oklahoma City, Oklahoma, United States
Virginia Adult & Pediatric Allergy and Asthma
🇺🇸
Richmond, Virginia, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
Vanderbilt Asthma Sinus Allergy Program & Research Centers
🇺🇸
Nashville, Tennessee, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States
Asthma, Inc
🇺🇸
Seatle, Washington, United States
Allergy, Asthma and Sinus Center
🇺🇸
Greenfield, Wisconsin, United States
St. Joseph's Healthcare
🇨🇦
Hamilton, Ontario, Canada
University of Wisconsin-Madison, Allergy/Asthma Clinical Research Unit
🇺🇸
Madison, Wisconsin, United States
Queen's University, Richardson's House
🇨🇦
Kingston, Ontario, Canada
The Ottawa Hospital
🇨🇦
Ottawa, Ontario, Canada
Hopital Laval
🇨🇦
Quebec, Canada
Hopital du Sacre-Couer de Montreal
🇨🇦
Montreal, Quebec, Canada
The Asthma & Allergy Center
🇺🇸
Papillion, Nebraska, United States
Heritage Medical Research Clinic, University of Calgary
🇨🇦
Calgary, Alberta, Canada