Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma

Phase 3

Completed

• Conditions: Allergic Asthma

• Registration Number: NCT00829179
• Lead Sponsor: Duke University

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 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.

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 one week apart. All subjects will receive treatment with RhuMAB-E25 in an open label fashion at day 0, weeks 4 and 8, and undergo methacholine challenge and NO measurement at screening/baseline, weeks 0, 6, and 12. Complete Blood Count (CBC) will be done at screening/baseline, weeks 1, 2, 4, 8, and week 12. For women of childbearing potential, a screening pregnancy test will be done. All statistical analysis will occur at the conclusion of this study.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Results First Submitted: 2009-02-22
• Results First Submitted QC: 2009-09-17
• Results First Posted: 2009-10-21
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Exhaled Nitric Oxide From Baseline to Week 12	13 weeks	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)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States