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View Clinical Trial (Medical Research Study)
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A Study to Evaluate the Efficacy of Xolair in Atopic Asthmatics - NCT00096954-53228 (Clinical Trial 122583)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy122583.aspx
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| City: |
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Greenfield |
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State:
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WI |
| Zip Code: |
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53228 |
| Conditions: |
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Asthma |
| Purpose: |
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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).
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Have a documented history of asthma as well as evidence of ≥ 12% reversibility of
FEV1. Evidence of ≥ 12% reversibility of FEV1 may be obtained by any one of the
following measures: 1) Documentation of ≥ 12% reversibility of FEV1 after albuterol
administration at any time during the preceding 24 months; 2) Documentation of ≥ 12%
improvement in FEV1 with two separate measurements obtained within a 4-week period
surrounding an asthma exacerbation during the preceding 24 months; 3) Demonstration
of ≥ 12%reversibility of FEV1 after albuterol administration at the time of screening
- Have screening FEV1 ≥ 80% predicted normal value
- Have a positive skin test (diameter of wheal ≥ 3 mm vs. control) or in vitro RAST(R)
or ImmunoCap(R) to one relevant perennial aeroallergen such as cat or house dust
mites documented within the previous year
- Be receiving at least an inhaled corticosteroid dosage of fluticasone dry powder
inhaler (DPI) ≥ 200 ug/day or equivalent ex-valve dose during the 12 weeks prior to
the screening visit
- Have had at least one asthma exacerbation requiring treatment with at least one
course of oral or intravenous corticosteroids or a doubling of the dose of inhaled
corticosteroids for at least 3 days in the 12 months prior to screening despite being
on a minimum of fluticasone DPI ≥ 200 ug/day or equivalent ex-valve dose
- During the 4-week run-in period prior to randomization, demonstrate evidence of
inadequate asthma symptom control despite inhaled corticosteroids with or without
other controller asthma medications (e.g., LABA, LTRA, immunotherapy). Inadequate
asthma symptom control is defined as at least one of the following reported on the
subject diary card during the 4-week run-in period: Daytime asthma symptoms as a
score of ≥ 1 (scale of 0-4) on at least 20 of 28 days (missing data to be treated as
a day with no symptoms) and a mean symptom score of ≥ 1.5 (mean will be calculated
based on only data supplied; missing values will not be considered) or Nighttime
awakening because of asthma symptoms (more than 4 times during the 4-week run-in
period)
- Meet the study drug-dosing table eligibility criteria (serum baseline IgE level ≥ 30
to ≤ 1300 IU/mL and body weight ≥ 20 to ≤ 150 kg)
- If a female of childbearing potential, use an effective method of contraception (in
the opinion of the investigator) to prevent pregnancy and agree to continue to
practice an acceptable method of contraception for the duration of their
participation in the study
Exclusion Criteria:
- Have received chronic systemic corticosteroids (oral or intravenous) within 3 months
or have received a burst of oral corticosteroids within the last 2 weeks prior to
screening
- Have received Xolair therapy at any time within 12 months prior to screening
- Are pregnant or lactating
- Have a known hypersensitivity to any ingredients of Xolair, including excipients
(sucrose, histidine, polysorbate 20)
- Have a lifetime history of smoking > 10-pack years
- Have active lung disease other than asthma (e.g., chronic bronchitis, emphysema,
cystic fibrosis, chronic obstructive pulmonary disease)
- Have a history of upper respiratory infection or lower respiratory infection within
the 30 days prior to randomization
- Have a diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma
- Have taken immunosuppressants or other investigational drugs within the 30 days prior
to screening
- Have a significant medical illness other than asthma |
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| Study is available at: |
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Allergy Asthma & Sinus Center
Greenfield, WI 53228
United States
Primary Contact:
Jenny Vick
Email: jenny@aasc-drsteven.com
Phone: 414-529-8519
Secondary Contact:
Trial Information Support Line
Phone: 888-662-6728 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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