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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00603785 |
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Date of registration:
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11/01/2008 |
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Primary sponsor: |
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Public title:
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Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis
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Scientific title:
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Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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25 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00603785 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Andrew Goldberg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and females between 18 and 75 years of age
- Chronic sinusitis as defined by symptoms for greater than 12 weeks despite treatment.
- Paranasal sinus CT scan showing evidence of chronic sinusitis.
- Positive skin or RAST test to an inhalant allergen.
- Serum total IgE between 30 and 700 International Units/ml.
- Body weight less than 150kg.
- Impaired quality of life as measured by the Rhinosinusitis Disability Index (RSDI).
Exclusion Criteria:
- Women of childbearing potential not using the contraception method(s) (Birth control
pills, depo Provera, double barrier) as well as women who are breastfeeding.
- Known sensitivity to Xolair
- Patients with severe medical conditions that in the view of the investigator
prohibits participation in the study (heart, lung, kidney, neurological, oncologic or
liver disease).
- Use of any other investigational agent in the last 30 days.
- No measurable disability on the RSDI.
- Immunocompromised patients or patients with ciliary disorders.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Sinusitis
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Intervention(s)
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Drug: Placebo
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Drug: Xolair
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Primary Outcome(s)
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Subjects will have QOL measures (RSDI, SNOT 20, SF-36), NPIF, and nasal lavage repeated. Exacerbations of sinusitis requiring additional treatments will be recorded. Paranasal sinus CT scans will be obtained at the screening and final visits
[Time Frame: At entry and every 4 weeks]
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Secondary ID(s)
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07030836
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BB-IND# 12452
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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