Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Tanox
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00264849
First received: December 12, 2005
Last updated: June 24, 2011
Last verified: June 2011
Results First Received: December 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Omalizumab
Other: Optimized asthma therapy

  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
No text entered.

Reporting Groups
  Description
OAT + Omalizumab During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
Optimized Asthma Treatment (OAT) During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.

Participant Flow:   Overall Study
    OAT + Omalizumab     Optimized Asthma Treatment (OAT)  
STARTED     275     131  
COMPLETED     253     106  
NOT COMPLETED     22     25  
Adverse Event                 7                 2  
Withdrawal by Subject                 7                 11  
Protocol Violation                 5                 3  
Lack of Efficacy                 1                 6  
Lost to Follow-up                 0                 2  
Death                 0                 1  
Administrative Problems                 2                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
OAT + Omalizumab During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
Optimized Asthma Treatment (OAT) During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Total Total of all reporting groups

Baseline Measures
    OAT + Omalizumab     Optimized Asthma Treatment (OAT)     Total  
Number of Participants  
[units: participants]
  272     128     400  
Age [1]
[units: participants]
     
<=18 years     5     0     5  
Between 18 and 65 years     250     118     368  
>=65 years     17     10     27  
Age  
[units: years]
Mean ± Standard Deviation
  45.6  ± 13.04     45.7  ± 12.57     45.7  ± 12.87  
Gender  
[units: participants]
     
Female     183     76     259  
Male     89     52     141  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     266     125     391  
More than one race     0     0     0  
Unknown or Not Reported     3     2     5  
[1] All demographic data is described for the Modified ITT population. The modified ITT population includes all randomized patients with at least one post-baseline efficacy assessment



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)   [ Time Frame: Weeks 16 and 32 ]

2.  Secondary:   Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32   [ Time Frame: Weeks 16 and 32 ]

3.  Secondary:   Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE   [ Time Frame: Weeks 16 and 32 ]

4.  Secondary:   Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32   [ Time Frame: Weeks 16 and 32 ]

5.  Secondary:   Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE   [ Time Frame: Weeks 16 and 32 ]

6.  Secondary:   Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)   [ Time Frame: Weeks 16 and 32 ]

7.  Secondary:   Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32   [ Time Frame: Baseline, Week 16, Week 32 ]

8.  Secondary:   Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period   [ Time Frame: 32 Weeks ]

9.  Secondary:   Medical Resource Utilization: Number of Participants With Combined Hospital Admissions, Emergency Room Visits, and Other Outpatient Clinical Visits Due to an Asthma Exacerbation During the 32 Week Treatment Period   [ Time Frame: 32 Weeks ]

10.  Secondary:   Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32   [ Time Frame: Weeks 16 and 32 ]

11.  Secondary:   Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32   [ Time Frame: Weeks 16 and 32 ]

12.  Secondary:   Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit   [ Time Frame: Baseline, Week 15, Week 31 ]

13.  Secondary:   Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31   [ Time Frame: Baseline, Week 15, Week 31 ]

14.  Secondary:   Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems   [ Time Frame: Baseline and Week 31 ]

15.  Secondary:   Changes From Baseline to Week 31 in the Percent Activity Impairment Due to Asthma Problems   [ Time Frame: Baseline and Week 31 ]


  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
  Hide More Information

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.


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: NCT00264849     History of Changes
Other Study ID Numbers: CIGE025A2425
Study First Received: December 12, 2005
Results First Received: December 3, 2010
Last Updated: June 24, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ministry of Health
Poland: Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency