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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 200 mg dose | Experimental |
| |
| Experimental 20 mg dose | Experimental |
| |
| Active Comparator Montelukast | Active Comparator |
| |
| Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-6950 | Drug | 200 mg QD, single dose |
| |
| ONO-6950 |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise | 60 minutes following the exercise challenge |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-30 min) | area under the concentration time curve integrating fall in FEV1 following exercise over the 30 minute interval immediately following exercise | 30 minutes following the exercise challenge |
| AUC (0-60 min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Clinical Site 110 | Los Angeles | California | 90025 | United States | ||
| San Diego Clinical Site 140 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000603360 | gemilukast |
| C093875 | montelukast |
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| Drug |
20 mg QD, single dose |
|
| Montelukast | Drug | 10 mg Montelukast, QD single dose |
|
| Placebo | Drug | Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner |
|
area under the concentration time curve integrating fall in FEV1 following exercise over the 60 minute interval immediately following exercise
| 60 minutes following the exercise challenge |
| Time to recovery of FEV1 to within 5% of the pre-exercise baseline | 90 minutes following the exercise challenge |
| Proportion of patients using a short acting beta agonist (rescue medication) | 90 minutes following the exercise challenge |
| Ratio of responder/non-responder in FEV1 | 60 minutes following the exercise challenge |
| San Diego |
| California |
| 92123 |
| United States |
| Denver Clinical Site 160 | Denver | Colorado | 80230 | United States |
| North Dartmouth Clincial Site 150 | North Dartmouth | Massachusetts | 02747 | United States |
| Minneapolis Clinical Site 190 | Minneapolis | Minnesota | 55402 | United States |
| Princeton Clinical Site 170 | Princeton | New Jersey | 08558 | United States |
| Raleigh Clinical Site 130 | Raleigh | North Carolina | 27607 | United States |
| New Braunfeis Clinical Site 120 | New Braunfels | Texas | 78130 | United States |
| San Antonio Clinical Site 180 | San Antonio | Texas | 78229 | United States |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |