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

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
John Sundy, Duke University Identifier:
First received: January 22, 2009
Last updated: January 12, 2016
Last verified: January 2016

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.

Condition Intervention Phase
Allergic Asthma Drug: RhuMab-E25 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Role of RhuMab-E25 in Reducing Exhaled NO in Allergic Asthma

Resource links provided by NLM:

Further study details as provided by John Sundy, Duke University:

Primary Outcome Measures:
  • Change in Exhaled Nitric Oxide From Baseline to Week 12 [ Time Frame: 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)

Enrollment: 20
Study Start Date: October 2002
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: RhuMab-E25
    three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.
    Other Name: Omalizumab
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00829179

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Genentech, Inc.
Principal Investigator: John S Sundy, MD Duke University Medical Director
  More Information

Responsible Party: John Sundy, Associate Professor, Duke University Identifier: NCT00829179     History of Changes
Other Study ID Numbers: 3403
GCRC 894
Study First Received: January 22, 2009
Results First Received: February 22, 2009
Last Updated: January 12, 2016

Keywords provided by John Sundy, Duke University:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents processed this record on August 18, 2017