Status:
COMPLETED
Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma
Lead Sponsor:
Duke University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Allergic Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A single center pilot study to determine the protective effects of RhuMAB-E25 on airway physiology and biology in allergic asthmatics that undergo bronchoprovocation with methacholine. The primary st...
Detailed Description
This is a single center prospective, open-label study. Eligible subjects will undergo two baseline measurements of exhaled Nitric Oxide (NO) before and after methacholine challenge testing at least on...
Eligibility Criteria
Inclusion
- Subjects must be at least 18 years of age,
- Must have an FEV1 of \> 70% of predicted,
- Must have evidence of bronchial hyperreactivity to methacholine as defined by a methacholine provocation causing a 20% or greater fall in FEV1 (PC20) \< 8 mg/ml
- Use of inhaled steroid is permitted; however, no change in inhaled steroid dosage will be permitted over the duration of study
- Must have a normal platelet count,
- Must be willing to and competent to sign the consent form
Exclusion
- Subjects that do not have allergic asthma will be excluded.
- Subjects with ER visits or upper respiratory infections within the last six weeks will be excluded.
- Subjects with tobacco use within the past year or \> 10 pack year history of tobacco use will be excluded.
- Subjects with serum IgE levels of less than 30 or greater than 700 Iu/mL will be excluded.
- Subjects that require oral steroid use will be excluded.
- Subjects who weigh \< 30 kg or \> 150 kg are excluded, and subjects with baseline IgE levels greater than 300 may be excluded, depending on weight
- Pregnant or nursing females will be excluded.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00829179
Start Date
October 1 2002
End Date
July 1 2004
Last Update
February 8 2016
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710