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

Allergic Asthma Clinical Trial

Official title:

Role of RhuMab-E25 in Reducing Exhaled NO in Allergic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829179
• Other study ID #: 3403
• Secondary ID: GCRC 894
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2009
• Last updated: January 12, 2016
• Start date: October 2002
• Est. completion date: July 2004

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• RhuMab-E25
three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No