Allergic Asthma Clinical Trial
Official title:
Role of RhuMab-E25 in Reducing Exhaled NO in Allergic Asthma
Verified date | January 2016 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 study objective determines the protective impact of RhuMAB-E25 on airway
inflammation as reflected in exhaled nitric oxide (NO) levels in allergic asthmatics.
The secondary objective determines the protective effect of rhuMAB E25 against airway
bronchoconstriction as reflected in the Provocative Concentration of methacholine to cause a
20% fall in FEV1(PC20) with methacholine challenge testing.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2004 |
Est. primary completion date | July 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Exhaled Nitric Oxide From Baseline to Week 12 | The primary outcome measure was the change in exhaled nitric oxide levels between baseline and week 12. 12 week value minus baseline value. (Baseline was -1 week, ie 1 week prior to the start of study drug) | 13 weeks | No |
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