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Effect of Anti-IgE in Non-Allergic Asthma

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ClinicalTrials.gov Identifier: NCT00162773
Recruitment Status : Terminated (PI left institution)
First Posted : September 13, 2005
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

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
Enrollment 29
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title All Participants
Hide Arm/Group Description

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

Period Title: Overall Study
Started 29
Completed 7
Not Completed 22
Reason Not Completed
P.I, Left institution. Study terminated             22
Arm/Group Title All Participants
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
>=18 and <=80 Number Analyzed 29 participants
29
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
15
  51.7%
Male
14
  48.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
 100.0%
1.Primary Outcome
Title Changes in Free Serum IgE Levels From Baseline
Hide Description [Not Specified]
Time Frame baseline to 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data, if any, are not available as this study has been terminated as the PI has left the institution. 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.
Arm/Group Title All Participants
Hide Arm/Group Description:

water injection

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

OR

Other Names:

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

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description

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

OR

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

All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   1/29 (3.45%)    
Infections and infestations   
Boil/Abscess/Cellulitis * [1]  1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One participant developed a skin and soft tissue infection at the injection site.
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
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