Status:
COMPLETED
Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Allergic Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in m...
Eligibility Criteria
Inclusion
- Patients 18-75 years of age with moderate to severe persistent allergic asthma receiving a high dose inhaled corticosteroid (≥800µg per day BDP or equivalent) and a regular long acting beta-agonist for at least 3 months prior to screening
- With a body weight between 20 and 150kg and a serum total IgE level of 30 to 700 IU/mL
- With ≥2% eosinophilia in induced sputum at screening
- With post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% predicted
- With a positive skin prick test (diameter of wheal ≥ 3 mm) or RAST test to at least one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
Exclusion
- Patients who've had an asthma exacerbation during the 4 weeks prior to randomization
- Current smokers, stopped smoking within the last 12 months or have a smoking history of \>10 pack years
- History of severe allergy to food or drugs
- Previous treatment with omalizumab
- Any patient considered to be unsuitable to bronchoscopy, according to the judgment of the investigator
- Other protocol-defined inclusion/exclusion criteria applied.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00670930
Start Date
April 1 2008
End Date
November 1 2011
Last Update
January 18 2013
Active Locations (16)
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1
Novartis Investigative Site
Denver, Colorado, United States, 80206
2
Novartis Investigative Site
St Louis, Missouri, United States, 63110
3
Novartis Investigative Site
Durham, North Carolina, United States, 27710
4
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19104