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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
200 mg QD, single dose
20 mg QD, single dose
10 mg Montelukast, QD single dose
Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner
Los Angeles Clinical Site 110
Los Angeles, California, United States
San Diego Clinical Site 140
San Diego, California, United States
Denver Clinical Site 160
Denver, Colorado, United States
North Dartmouth Clincial Site 150
North Dartmouth, Massachusetts, United States
Minneapolis Clinical Site 190
Minneapolis, Minnesota, United States
Princeton Clinical Site 170
Princeton, New Jersey, United States
Raleigh Clinical Site 130
Raleigh, North Carolina, United States
New Braunfeis Clinical Site 120
New Braunfels, Texas, United States
San Antonio Clinical Site 180
San Antonio, Texas, United States
Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise
Time frame: 60 minutes following the exercise challenge
AUC (0-30 min)
area under the concentration time curve integrating fall in FEV1 following exercise over the 30 minute interval immediately following exercise
Time frame: 30 minutes following the exercise challenge
AUC (0-60 min)
area under the concentration time curve integrating fall in FEV1 following exercise over the 60 minute interval immediately following exercise
Time frame: 60 minutes following the exercise challenge
Time to recovery of FEV1 to within 5% of the pre-exercise baseline
Time frame: 90 minutes following the exercise challenge
Proportion of patients using a short acting beta agonist (rescue medication)
Time frame: 90 minutes following the exercise challenge
Ratio of responder/non-responder in FEV1
Time frame: 60 minutes following the exercise challenge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.