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) - 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

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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 ]

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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 ]

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Measure Type	Secondary
Measure Title	Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period
Measure Description	The number of patients reporting one or more protocol-defined asthma exacerbations during the 24 week treatment period. A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.
Time Frame	Start of treatment to 24 weeks
Safety Issue	No

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.
Modified Intent-to-Treat - All randomly assigned patients who received at least 1 dose of study drug (omalizumab or placebo).

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.

Measured Values

	Omalizumab (Xolair)	Placebo
Number of Participants Analyzed [units: participants]	157	171
Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period [units: participants]	24	33

No statistical analysis provided for Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period

3. Secondary:

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

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4. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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
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