A Study of Xolair in Subjects With Moderate to Severe Persistent Asthma (EXTRA) - Full Text View

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00314574

Purpose

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy to high-dose ICS+LABA for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose ICS+LABA.

Condition	Intervention	Phase
Asthma	Drug: omalizumab Drug: placebo Drug: corticosteroids Drug: long-acting beta-agonists	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Xolair in Subjects With Moderate to Severe Persistent Asthma Who Are Inadequately Controlled With High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab Corticosteroids

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Rate of asthma exacerbations [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The change in overall asthma-related quality of life [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
The change in nocturnal and daytime asthma symptom scores [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
The change in the number of puffs per day of beta agonist rescue medication [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Frequency and severity of treatment-emergent adverse events [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment:	860
Study Start Date:	April 2006
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: omalizumab Subcutaneous repeating dose Drug: corticosteroids Inhaled repeating dose Drug: long-acting beta-agonists Inhaled repeating dose
2: Placebo Comparator	Drug: placebo Subcutaneous repeating dose Drug: corticosteroids Inhaled repeating dose Drug: long-acting beta-agonists Inhaled repeating dose

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed Informed Consent Form and an informed assent, if applicable
Be between the ages of 12 to 75 years
Have had a history of moderate to severe asthma for at least one year prior to screening
Have had treatment with a stable regimen of of salmeterol 50 mcg BID or formoterol 12 mcg BID for at least 8 weeks prior to screening
Have had treatment with a stable regimen of high-dose ICS for at least 8 weeks prior to screening
Have inadequately controlled asthma
Have had at least one asthma exacerbation requiring systemic corticosteroid rescue in the 12 months prior to the screening visit while receiving treatment with high-dose ICS
Have less than 10 pack-years smoking history
Have a positive skin test for or a positive, in vitro response to one relevant perennial aeroallergen documented within the 12 months prior to screening
If a subject has not had a positive skin test or in vitro reactivity in the 12 months prior to screening, the subject must demonstrate a positive response to at least one relevant perennial aeroallergen in a skin or in vitro test prior to randomization
Female subjects of childbearing potential must use an effective method of contraception from screening through their duration of participation in the study
For the collection of additional blood samples for future research (optional), provide signed consent and an informed assent, if applicable.

Exclusion Criteria:

Have had an asthma exacerbation requiring intubation within 12 months prior to screening
Have active lung disease other than asthma
Have had an asthma exacerbation requiring treatment with the addition of systemic (oral or intravenous) corticosteroids or an increase in systemic corticosteroids within 30 days prior to screening
Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc.
Have significant medical illness other than asthma
Have taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics, within 3 months prior to screening
Have taken other investigational drugs within 30 days prior to screening
Have been treated with Xolair within the 12 months prior to screening
Have a history of drug or alcohol abuse that, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study
Have elevated serum IgE levels for reasons other than allergy
Are pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314574

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Karin Rosen, M.D., Ph.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	Q3662g
Study First Received:	April 12, 2006
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00314574 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Persistent Asthma
EXTRA
Xolair
Difficult Breathing

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Omalizumab

ClinicalTrials.gov processed this record on February 08, 2010