Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Ception Therapeutics )
First received: January 4, 2008
Last updated: August 16, 2013
Last verified: August 2013
The purpose of this study is to determine the effectiveness and safety of reslizumab (the drug under study) in the treatment of subjects with poorly controlled asthma.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation
Primary Outcome Measures:
- Asthma Control Questionnaire [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Forced expiratory volume in the first second [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- Number of asthma exacerbations [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- Eosinophil levels [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2010 (Final data collection date for primary outcome measure)
Reslizumab 3 mg/kg
IV (in the vein) on Day 0 of each 28 day cycle (+/- 7 days) Number of Cycles=4
Other Name: Cinquil™
Placebo Comparator: 2
IV (in the vein) on Day 0 of each 28 day cycle (+/-7 days) Number of Cycles=4
Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation.
- 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 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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- written informed consent
- male or female subjects aged ≥ 18 to 75 years at time of screening.
- female if she is of non-childbearing potential, 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 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
- 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-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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587288
||Sponsor's Medical Expert, MD
No publications provided
||Teva Pharmaceutical Industries ( Ception Therapeutics )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 4, 2008
||August 16, 2013
||Canada: Health Canada
Canada: Ethics Review Committee
United States: Food and Drug Administration
United States: Institutional Review Board
Keywords provided by Teva Pharmaceutical Industries:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases