NCT00829179

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	RhuMab-E25	three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.

Timeline

• Start date: 2002-10-01
• Primary completion: 2004-07-01
• Completion: 2004-07-01
• First posted: 2009-01-26
• Last updated: 2016-02-08
• Results posted: 2009-10-21

Locations

1 site across 1 country: United States