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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00829179
Recruitment Status : Completed
First Posted : January 26, 2009
Results First Posted : October 21, 2009
Last Update Posted : February 8, 2016
Genentech, Inc.
Information provided by (Responsible Party):
John Sundy, 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.

Condition or disease Intervention/treatment Phase
Allergic Asthma Drug: RhuMab-E25 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : October 2002
Primary Completion Date : July 2004
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Intervention Details:
    Drug: RhuMab-E25
    three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.
    Other Name: Omalizumab

Primary Outcome Measures :
  1. 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)

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: John Sundy, Associate Professor, Duke University Identifier: NCT00829179     History of Changes
Other Study ID Numbers: 3403
GCRC 894
First Posted: January 26, 2009    Key Record Dates
Results First Posted: October 21, 2009
Last Update Posted: February 8, 2016
Last Verified: January 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