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Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00454051
First received: March 28, 2007
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
Results First Received: December 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Omalizumab
Drug: placebo

  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
Omalizumab Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Participant Flow:   Overall Study
    Omalizumab     Placebo  
STARTED     20     11  
COMPLETED     17     8  
NOT COMPLETED     3     3  
Adverse Event                 1                 2  
Withdrawal by Subject                 1                 0  
Protocol Violation                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Omalizumab Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
Total Total of all reporting groups

Baseline Measures
    Omalizumab     Placebo     Total  
Number of Participants  
[units: participants]
 		  20     11     31  
Age  
[units: years]
Mean ± Standard Deviation 		  45.7  ± 13.30     50.6  ± 16.31     47.4  ± 14.37  
Gender  
[units: participants]
 		     
Female     14     5     19  
Male     6     6     12  



  Outcome Measures
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1.  Primary:   Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo   [ Time Frame: Baseline and Week 16 ]
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2.  Primary:   Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo   [ Time Frame: Baseline and Week 16 ]
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3.  Secondary:   Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment   [ Time Frame: Baseline, Weeks 4, 8, 12 and 16 ]
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4.  Secondary:   Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment   [ Time Frame: Baseline, Weeks 4, 8, 12, and 16 ]
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5.  Secondary:   Change From Baseline in the Number of Days With Asthma Symptoms Per Week   [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]
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6.  Secondary:   Change From Baseline in the Number of Puffs of Rescue Medication Per Week   [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]
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7.  Secondary:   Change From Baseline in the Number of Nights With Awakenings Per Week   [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]
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8.  Secondary:   Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week   [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]
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9.  Secondary:   Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms   [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]
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10.  Secondary:   Change From Baseline in the Number of Days With Hospitalizations   [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]
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11.  Secondary:   Change From Baseline in the Number of Unscheduled Clinic Visits   [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]
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12.  Secondary:   Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)   [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]
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13.  Secondary:   Physician's Overall Assessment of Treatment Effectiveness   [ Time Frame: After 16 weeks of treatment ]
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  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
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:


Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00454051     History of Changes
Other Study ID Numbers: CIGE025AFR02
Study First Received: March 28, 2007
Results First Received: December 3, 2010
Last Updated: August 2, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)