Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Ception Therapeutics )
ClinicalTrials.gov Identifier:
NCT00587288
First received: January 4, 2008
Last updated: July 18, 2016
Last verified: July 2016
Results First Received: March 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Biological: Reslizumab
Other: Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Reslizumab 3 mg/kg reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Placebo saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles

Participant Flow:   Overall Study
    Reslizumab 3 mg/kg   Placebo
STARTED   53   53 
COMPLETED   50   44 
NOT COMPLETED   3   9 
Adverse Event                0                1 
Lack of Efficacy                2                8 
Protocol Violation                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Reslizumab 3 mg/kg reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Placebo saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
Total Total of all reporting groups

Baseline Measures
   Reslizumab 3 mg/kg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   53   106 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.9  (13.94)   45.8  (11.74)   45.4  (12.83) 
Age, Customized 
[Units: Participants]
     
18 to < 45 years   28   20   48 
45 to < 65 years   19   32   51 
>/= 65 years   6   1   7 
Gender 
[Units: Participants]
     
Female   34   29   63 
Male   19   24   43 


  Outcome Measures
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1.  Primary:   Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score   [ Time Frame: Baseline through End of Therapy (up to 15 weeks) ]

2.  Secondary:   Percentage of ACQ Responders at End of Therapy   [ Time Frame: Baseline, End of Therapy (up to 15 weeks) ]

3.  Secondary:   Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)   [ Time Frame: Baseline, End of Therapy (up to 15 weeks) ]

4.  Secondary:   Change From Baseline to End of Therapy in Percent Predicted FEV1   [ Time Frame: Baseline, End of Therapy (up to 15 weeks) ]

5.  Secondary:   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) ]

6.  Secondary:   Percentage of Participants With Clinical Asthma Exacerbations (CAEs)   [ Time Frame: up to 15 weeks ]

7.  Secondary:   Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation   [ Time Frame: From start of study drug through 15 weeks + 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com


Publications:

Responsible Party: Teva Pharmaceutical Industries ( Ception Therapeutics )
ClinicalTrials.gov Identifier: NCT00587288     History of Changes
Other Study ID Numbers: Res-5-0010
Study First Received: January 4, 2008
Results First Received: March 23, 2016
Last Updated: July 18, 2016
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee
United States: Food and Drug Administration
United States: Institutional Review Board