CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
RhuMab-E25drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00829179
NCT00829179Phase 3Completed
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Role of RhuMab-E25 in Reducing Exhaled NO in Allergic Asthma

Duke University·interventional·Posted Jan 26, 2009·Updated Feb 8, 2016

In Brief

A Phase 3 clinical trial evaluating RhuMab-E25 for Allergic Asthma. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Asthma
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 26, 2009
Enrollment StartOct 1, 2002
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.4 years ago

Interventions

RhuMab-E25drug

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