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

Primary Purpose

Allergic Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RhuMab-E25
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Allergic Asthma focused on measuring Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Outcomes

Primary Outcome Measures

Change in Exhaled Nitric Oxide From Baseline to Week 12
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)

Secondary Outcome Measures

Full Information

First Posted
January 22, 2009
Last Updated
January 12, 2016
Sponsor
Duke University
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00829179
Brief Title
Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma
Official Title
Role of RhuMab-E25 in Reducing Exhaled NO in Allergic Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke University
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
RhuMab-E25
Other Intervention Name(s)
Omalizumab
Intervention Description
three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.
Primary Outcome Measure Information:
Title
Change in Exhaled Nitric Oxide From Baseline to Week 12
Description
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)
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Sundy, MD
Organizational Affiliation
Duke University Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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

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