A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA) - Study Results

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 Drug: corticosteroids Drug: long-acting beta-agonists

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
Placebo	Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study.
Xolair	Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study.

Description

Placebo

Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.

Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.

Participants were permitted to use albuterol as rescue medicine throughout the study.

Xolair

Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.

Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.

Participants were permitted to use albuterol as rescue medicine throughout the study.

Participant Flow: Overall Study

	Placebo	Xolair
STARTED	423	427
Received at Least One Dose of Study Drug	421	427
Safety Population	420 ^[1]	428
COMPLETED	329	344
NOT COMPLETED	94	83
Death	3	0
Adverse Event	11	16
Lost to Follow-up	19	25
Withdrawal by Subject	33	22
Physician Decision	22	15
Pregnancy	6	4
Data unknown at database lock	0	1

[1]	1 patient in the placebo arm received Xolair and was added to the Xolair arm for Safety analyses.

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Placebo	Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study.
Xolair	Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study.

Description

Placebo

Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.

Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.

Participants were permitted to use albuterol as rescue medicine throughout the study.

Xolair

Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.

Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.

Participants were permitted to use albuterol as rescue medicine throughout the study.

Baseline Measures

	Placebo	Xolair	Total
Number of Participants [units: participants]	421	427	848
Age ^[1] [units: participants]
<=18 years	16	23	39
Between 18 and 65 years	376	379	755
>=65 years	29	25	54
Age [units: years] Mean ± Standard Deviation	45.3 ± 13.9	43.7 ± 14.3	44.5 ± 14.1
Gender [units: participants]
Female	295	262	557
Male	126	165	291

[1]	All baseline measures were based on all randomized subjects who received at least one dose of study drug (the modified ITT population). The modified ITT population included 848 subjects (427 subjects in the Xolair group and 421 subjects in the placebo group).

Outcome Measures

Show All Outcome Measures

1. Primary:

Rate of Asthma Exacerbations Over the 48 Week Treatment Period [ Time Frame: 48 weeks ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline in Total Asthma Symptom Scores [ Time Frame: Baseline and Week 48 ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in the Number of Puffs Per Day of Beta Agonist Rescue Medication [ Time Frame: Baseline and Week 48 ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in Overall Asthma-related Quality of Life [ Time Frame: Baseline and Week 48 ]

Show Outcome Measure 4

5. Secondary:

Number of Participants Assessed for Frequency and Severity of Treatment-emergent Adverse Events [ Time Frame: Week 48 ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights."

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.

Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT00314574 History of Changes
Other Study ID Numbers:	Q3662g
Study First Received:	April 12, 2006
Results First Received:	March 31, 2011
Last Updated:	February 8, 2012
Health Authority:	United States: Food and Drug Administration