Phase 3
N=20
Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma
Allergic Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00829179 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2009
Primary outcome: Primary: Change in Exhaled Nitric Oxide From Baseline to Week 12 — -11.0 parts per billion (ppb) — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RhuMab-E25 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Exhaled Nitric Oxide From Baseline to Week 12 |
-11.0 | 0.005 sig |
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.
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) 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 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.
Data sourced from ClinicalTrials.gov (NCT00829179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.