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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
John Sundy, Duke University
ClinicalTrials.gov Identifier:
NCT00829179
First received: January 22, 2009
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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: 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 Duke University:

Primary Outcome Measures:
  • Change in Exhaled Nitric Oxide From Baseline to Week 12 [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829179

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

No publications provided

Responsible Party: John Sundy, Associate Professor, Duke University
ClinicalTrials.gov 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: March 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014