Allergic Asthma Clinical Trial
Official title:
Role of RhuMab-E25 in Reducing Exhaled NO in Allergic Asthma
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.
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. ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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