NCT00829179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 21, 2009

Completed
Last Updated

February 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

January 22, 2009

Results QC Date

February 22, 2009

Last Update Submit

January 12, 2016

Conditions

Allergic Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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)

    13 weeks

Interventions

RhuMab-E25DRUG

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

Also known as: Omalizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

rhuMAb-E25Omalizumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Limitations and Caveats

Pilot study with small sample size.

Results Point of Contact

Title
John S. Sundy M.D. PhD
Organization
Duke University Medical Center
john.sundy@duke.edu
(919) 668-2169

Study Officials

  • John S Sundy, MD

    Duke University Medical Director

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

October 1, 2002

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

February 8, 2016

Results First Posted

October 21, 2009

Record last verified: 2016-01

Locations

US(1)