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Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Ellen Dutta, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01066104
First received: February 8, 2010
Last updated: April 14, 2017
Last verified: April 2017
Results First Received: February 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Conditions: Chronic Rhinosinusitis
Nasal Polyps
Interventions: Drug: Xolair placebo
Drug: Xolair (omalizumab)

  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
Xolair Placebo Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Xolair (Omalizumab) Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)

Participant Flow:   Overall Study
    Xolair Placebo   Xolair (Omalizumab)
STARTED   14   13 
COMPLETED   12   12 
NOT COMPLETED   2   1 
Adverse Event                1                1 
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.
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Reporting Groups
  Description
Xolair Placebo Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Xolair (Omalizumab) Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Total Total of all reporting groups

Baseline Measures
   Xolair Placebo   Xolair (Omalizumab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   13   27 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 14   13   27 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      14 100.0%      13 100.0%      27 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 12   12   24 
Female      4  33.3%      3  25.0%      7  29.2% 
Male      8  66.7%      9  75.0%      17  70.8% 
[1] 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 12   12   24 
Hispanic or Latino      2  16.7%      1   8.3%      3  12.5% 
Not Hispanic or Latino      10  83.3%      11  91.7%      21  87.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
[1] 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 12   12   24 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  25.0%      1   8.3%      4  16.7% 
White      8  66.7%      10  83.3%      18  75.0% 
More than one race      1   8.3%      0   0.0%      1   4.2% 
Unknown or Not Reported      0   0.0%      1   8.3%      1   4.2% 
[1] 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.


  Outcome Measures
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1.  Primary:   Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan.   [ Time Frame: 4 months ]

2.  Secondary:   Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination.   [ Time Frame: 4 months ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ellen Dutta
Organization: MGH
phone: 6177248256
e-mail: edutta@mgh.harvard.edu



Responsible Party: Ellen Dutta, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01066104     History of Changes
Other Study ID Numbers: 2009P001325
Study First Received: February 8, 2010
Results First Received: February 24, 2017
Last Updated: April 14, 2017