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| Sponsor: | Genentech |
|---|---|
| Information provided by (Responsible Party): | Genentech |
| ClinicalTrials.gov Identifier: | NCT00096954 |
Purpose
This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were 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 (Xolair) Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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) |
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.
The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 week treatment period in each treatment group.
The daytime asthma symptom score assessed the symptoms: shortness of breath, chest discomfort, wheezing, and cough over the previous 24 hour period on a scale of 0(no symptoms) to 4(marked discomfort).
The nocturnal asthma score was the patient's response to:How did you sleep last night? rated on a scale of 0(no problems) to 4(difficulty sleeping;rescue medicine used).
Scores were collected daily. Change from Baseline (mean of last 28 days prior to first dosing date) at Week 24 (mean of last 28 days prior to week 24 visit).
A negative change from baseline score indicates improvement.
Spirometry was used to assess FEV1. All spirometry measurements were performed in accordance with the American Thoracic Society (ATS) guidelines.
The relative percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was calculated at week 24 using the formula: (FEV1 at week 24 - FEV1 at baseline) / FEV1 at baseline * 100 for each treatment group.
| Enrollment: | 333 |
| Study Start Date: | December 2005 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Omalizumab
Omalizumab (Xolair) administered in this study was either a 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.
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Drug: 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.
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Placebo Comparator: Placebo
Placebo administered in this study was either a 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.
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Drug: 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.
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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
More Information
| 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 |
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Omalizumab (Xolair) Atopic Asthma |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Omalizumab Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |