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

NCT ID: NCT00829179

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2004-07-31

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.

Conditions

Allergic Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

RhuMab-E25

three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.

Intervention Type: DRUG

Other Intervention Names

Omalizumab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

John Sundy

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John S Sundy, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Director

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

GCRC 894

Identifier Type: -

Identifier Source: secondary_id

3403

Identifier Type: -

Identifier Source: org_study_id