search
Back to results

Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Reslizumab
Saline
Sponsored by
Ception Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Cinquil™, Reslizumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children'S Hospital of Orange County-Pediatric Subspecialty Faculty
  • Allergy & Clinical Research Center
  • Asthma & Allergy Associates, P.C.
  • National Jewish Medical & Research Center
  • Sneeze, Wheeze & Itch Associates, LLC
  • Pulmonary Disease & Critical Care Associates, P.A.
  • Brigham and Women's Hospital
  • Clinical Research Institute
  • Washington University of School of Medicine
  • The Asthma & Allergy Center
  • Health Sciences Research at Asthma & Allergy
  • Wake Forest Univeristy Health Services
  • David Bernstein
  • Toledo Center for Clinical Research
  • Allergy, Asthma and Clinical Research Center
  • Clinical Research Institute of Southern Oregon
  • Allergy and Asthma Specialists
  • University of Pittsburgh
  • Vanderbilt Asthma Sinus Allergy Program & Research Centers
  • Virginia Adult & Pediatric Allergy and Asthma
  • Virginia Commonwealth University
  • Asthma, Inc
  • Allergy, Asthma and Sinus Center
  • University of Wisconsin-Madison, Allergy/Asthma Clinical Research Unit
  • Heritage Medical Research Clinic, University of Calgary
  • St. Joseph's Healthcare
  • Queen's University, Richardson's House
  • The Ottawa Hospital
  • Hopital du Sacre-Couer de Montreal
  • Hopital Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reslizumab 3 mg/kg

Placebo

Arm Description

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

Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels
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.
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.

Full Information

First Posted
January 4, 2008
Last Updated
July 18, 2016
Sponsor
Ception Therapeutics
Collaborators
Cephalon
search

1. Study Identification

Unique Protocol Identification Number
NCT00587288
Brief Title
Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
Official Title
An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ception Therapeutics
Collaborators
Cephalon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Cinquil™, Reslizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reslizumab 3 mg/kg
Arm Type
Experimental
Arm Description
Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Intervention Type
Biological
Intervention Name(s)
Reslizumab
Other Intervention Name(s)
Cinquil™, CEP-38072, CTx55700
Intervention Type
Other
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score
Description
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)
Secondary Outcome Measure Information:
Title
Percentage of ACQ Responders at End of Therapy
Description
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)
Title
Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)
Description
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)
Title
Change From Baseline to End of Therapy in Percent Predicted FEV1
Description
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)
Title
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)
Title
Percentage of Participants With Clinical Asthma Exacerbations (CAEs)
Description
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
Title
Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sponsor's Medical Expert, MD
Organizational Affiliation
Cephalon (Ception)
Official's Role
Study Director
Facility Information:
Facility Name
Children'S Hospital of Orange County-Pediatric Subspecialty Faculty
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Allergy & Clinical Research Center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Asthma & Allergy Associates, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
National Jewish Medical & Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Sneeze, Wheeze & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Pulmonary Disease & Critical Care Associates, P.A.
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Washington University of School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Asthma & Allergy Center
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Health Sciences Research at Asthma & Allergy
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Wake Forest Univeristy Health Services
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
David Bernstein
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Toledo Center for Clinical Research
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Allergy, Asthma and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy and Asthma Specialists
City
Blue Bell
State/Province
Pennsylvania
ZIP/Postal Code
19422
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt Asthma Sinus Allergy Program & Research Centers
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Virginia Adult & Pediatric Allergy and Asthma
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Asthma, Inc
City
Seatle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Allergy, Asthma and Sinus Center
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
University of Wisconsin-Madison, Allergy/Asthma Clinical Research Unit
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53972
Country
United States
Facility Name
Heritage Medical Research Clinic, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Queen's University, Richardson's House
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V6
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Hopital du Sacre-Couer de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
Hopital Laval
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21852542
Citation
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.
Results Reference
background

Learn more about this trial

Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

We'll reach out to this number within 24 hrs