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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00096954 |
Purpose
This is a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that will enroll approximately 300 subjects. These subjects will be 12-75 years old with atopic asthma, have a history of asthma exacerbations, have elevated serum total IgE, have a baseline FEV1 ≥ 80% predicted, and be on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor antagonist [LTRA], or immunotherapy).
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: omalizumab Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | A Prospective, Randomized, Double-Blind Study of the Efficacy of Xolair in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT) |
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2005 |
| Estimated Primary Completion Date: | May 2022 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: omalizumab
subcutaneous injection
|
| 2: Placebo Comparator |
Drug: placebo
subcutaneous injection
|
Eligibility| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Trial Information Support Line | 888-662-6728 |
Show 56 Study Locations| Study Director: | Dana McClintock, M.D. | Genentech |
More Information
| Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
| Study ID Numbers: | Q2982g |
| Study First Received: | November 17, 2004 |
| Last Updated: | August 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00096954 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Xolair Atopic Asthma |
|
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 |