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

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.

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.