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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:
ClinicalTrials.gov Identifier:
NCT00267202
First Posted: December 20, 2005
Last Update Posted: September 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Genentech, Inc.
Tanox
Information provided by (Responsible Party):
Novartis
Results First Submitted: November 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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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
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 
Overall Participants Analyzed 
[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/Ethnicity, Customized 
[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 ]

2.  Secondary:   Severity of First Systemic Allergic Reaction (SAR)   [ Time Frame: 26 Weeks ]

3.  Secondary:   Number of Participants Who Achieved Target Maintenance Specific Immunotherapy (SIT) Dose   [ Time Frame: 16 Weeks ]

4.  Secondary:   Number of Participants Requiring 8 to 20 Visits to Complete Cluster Specific Immunotherapy (SIT) Dosing Regimen   [ Time Frame: Up to 26 Weeks ]

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 ]


  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: Clinical Director
Organization: Novartis Pharmaceuticals
phone: 862-778-1768
e-mail: maria.figliomeni@novartis.com



Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00267202     History of Changes
Other Study ID Numbers: CIGE025AUS23
First Submitted: December 19, 2005
First Posted: December 20, 2005
Results First Submitted: November 22, 2010
Results First Posted: May 16, 2011
Last Update Posted: September 14, 2016