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Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma

This study has been completed.
Sponsor:
Collaborators:
Genentech
Tanox
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00267202
First received: December 19, 2005
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
Results First Received: November 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Allergic Asthma
Interventions: Drug: Placebo
Drug: Omalizumab
Drug: Immunotherapy

  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
Placebo The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
Omalizumab The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.

Participant Flow:   Overall Study
    Placebo     Omalizumab  
STARTED     136     139  
COMPLETED     83     105  
NOT COMPLETED     53     34  
Unsatisfactory therapeutic effect                 21                 8  
Withdrawal by Subject                 12                 15  
Adverse Event                 13                 7  
Protocol Violation                 2                 3  
Administrative problems                 2                 1  
Lost to Follow-up                 3                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
Omalizumab The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
Total Total of all reporting groups

Baseline Measures
    Placebo     Omalizumab     Total  
Number of Participants  
[units: participants]
 		  136     139     275  
Age  
[units: years]
Mean ± Standard Deviation 		  38.2  ± 10.02     38.2  ± 9.89     38.2  ± 9.93  
Gender  
[units: participants]
 		     
Female     99     88     187  
Male     37     51     88  
Race (NIH/OMB)  
[units: participants]
 		     
Asian     0     1     1  
Black or African American     11     17     28  
White     112     118     230  
Unknown or Not Reported     13     3     16  



  Outcome Measures
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1.  Primary:   Number of Participants With Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT)   [ Time Frame: 26 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Severity of First Systemic Allergic Reaction (SAR)   [ Time Frame: 26 Weeks ]
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3.  Secondary:   Number of Participants Who Achieved Target Maintenance Specific Immunotherapy (SIT) Dose   [ Time Frame: 16 Weeks ]
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4.  Secondary:   Number of Participants Requiring 8 to 20 Visits to Complete Cluster Specific Immunotherapy (SIT) Dosing Regimen   [ Time Frame: Up to 26 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants Requiring 0 to >=5 Doses of Rescue Medications for Systemic Allergic Reactions (SARs) to Specific Immunotherapy (SIT)   [ Time Frame: Up to 26 Weeks ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Clinical Director
Organization: Novartis Pharmaceuticals
phone: 862-778-1768
e-mail: maria.figliomeni@novartis.com


No publications provided


Responsible Party: Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00267202     History of Changes
Other Study ID Numbers: CIGE025AUS23
Study First Received: December 19, 2005
Results First Received: November 22, 2010
Last Updated: October 27, 2011
Health Authority: United States: Food and Drug Administration