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Effect of Anti-IgE in Non-Allergic Asthma

This study has been terminated.
(PI left institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162773
First Posted: September 13, 2005
Last Update Posted: August 28, 2017
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: June 29, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: omalizumab
Other: Placebo

  Participant Flow
  Hide Participant Flow

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
The arms/groups were combined for the study due to the study's early termination and the PI's departure from the institution. Data obtained were from the IRB and are therefore not separated by arm. This is all that is available.

Reporting Groups
  Description
All Participants

water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.

OR

Other Names:

Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks


Participant Flow:   Overall Study
    All Participants
STARTED   29 
COMPLETED   7 
NOT COMPLETED   22 
P.I, Left institution. Study terminated                22 



  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
All Participants

water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.

OR

Other Names:

Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks omalizumab: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.


Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age, Customized 
[Units: Participants]
Count of Participants
 
>=18 and <=80   29 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  51.7% 
Male      14  48.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   29 


  Outcome Measures

1.  Primary:   Changes in Free Serum IgE Levels From Baseline   [ Time Frame: baseline to 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Clinical Trials Program JHU ICTR
Organization: Johns Hopkins University School of Medicine
phone: 410-550-6484
e-mail: registerclinicaltrials@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00162773     History of Changes
Other Study ID Numbers: 04-10-25-03
First Submitted: September 8, 2005
First Posted: September 13, 2005
Results First Submitted: June 29, 2017
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017