A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00096954
First received: November 17, 2004
Last updated: November 3, 2011
Last verified: November 2011
Results First Received: August 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: omalizumab (Xolair)
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
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
Omalizumab (Xolair) Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
Placebo The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.

Participant Flow:   Overall Study
    Omalizumab (Xolair)     Placebo  
STARTED     159     174  
Received Study Drug     157     171  
COMPLETED     135     154  
NOT COMPLETED     24     20  
Adverse Event                 3                 1  
Withdrawal by Subject                 9                 8  
Physician Decision                 1                 1  
Sponsors Decision                 1                 1  
Pregnancy                 1                 1  
Initiation of immunotherapy                 1                 0  
Non-compliance                 0                 3  
Lost to Follow-up                 8                 5  



  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
Omalizumab (Xolair) Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
Placebo The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Omalizumab (Xolair)     Placebo     Total  
Number of Participants  
[units: participants]
  157     171     328  
Age  
[units: years]
Mean ± Standard Deviation
  36.0  ± 14.7     38.1  ± 15.1     37.1  ± 14.9  
Gender [1]
[units: participants]
     
Female     110     116     226  
Male     47     55     102  
[1] Baseline characteristic numbers reflect the number of participants who received at least one dose of drug. Two participants in the Xolair group and three participants in the placebo group were not dosed.



  Outcome Measures
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1.  Primary:   Rate of Asthma Exacerbations Over the 24 Week Treatment Period   [ Time Frame: Start of treatment to 24 weeks ]

2.  Secondary:   Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period   [ Time Frame: Start of treatment to 24 weeks ]

3.  Secondary:   Change From Baseline in Nocturnal and Daytime Asthma Symptom Scores at Week 24   [ Time Frame: Baseline and 24 weeks ]

4.  Secondary:   Relative Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24   [ Time Frame: Baseline and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
This is a stand-alone study to fulfill one of the post-marketing commitments.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00096954     History of Changes
Other Study ID Numbers: Q2982g
Study First Received: November 17, 2004
Results First Received: August 8, 2011
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration