A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The primary objectives of this study are:
i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on
exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced
expiratory volume in 1 second (FEV1) after exercise challenge
ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg
of ONO-6950 in asthmatic patients.
The secondary objectives of this study are:
i. to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus
montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise
challenge
ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg)
single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.