A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients

The study will examine if ONO-6950 could alleviate EIB in asthmatic patients. Eligible
patients will complete a randomized, double-blind, four-way crossover study. During each of
four evaluation periods, patients will be administered a single dose of either 20 or 200 mg
ONO-6950, 10 mg Montelukast, or placebo. Each evaluation period include various assessments
following exercise challenge in an ambulatory setting.

Inclusion Criteria:

- Patients of both genders, between 18 to 60 years of age, with bronchial asthma for at
least 6 months and history of exercise induced bronchospasm

- Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for
at least 8 hours prior to testing

- Screening exercise challenge demonstrates that the patient experiences a fall in FEV1
of ≥ 20%

- Non-smokers with free from the usage of nicotine-containing products at least for a
year prior to screening

Exclusion Criteria:

- Previous history of life-threatening asthma, respiratory tract infection and/or
exacerbation of asthma within 6 weeks prior to the first screening visit

- History of being unable to tolerate or complete an exercise challenge and clinically
significant multiple drug or food allergies

- Past or present disorders and diseases including, but are not limited to
cardiovascular, malignancy, hepatic, renal, hematological, neurological, psychiatric,
endocrine, or pulmonary other than asthma

- Patients with Seasonal Allergic Rhinitis (SAR) or seasonal allergic asthma,with
significant symptoms that may confound study assessment

- Significant safety laboratory, ECG, or vital sign abnormalities that would place the
patient at undue risk during the study procedures