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



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:March 2012
Contact:Brenda Souza
Phone:609-512-4129

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A Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Safety and Efficacy of ONO-6950 20 mg and 200 mg QD Versus Placebo and Montelukast (Singulair) in Asthmatic Patients Who Experience Exercise-induced Bronchoconstriction


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.

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
We found this trial at
9
sites
Princeton, New Jersey 08558
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Denver, Colorado 80230
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Denver, CO
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Los Angeles, California 90025
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Los Angeles, CA
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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New Braunfels, Texas 78130
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New Braunfels, TX
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North Dartmouth, Massachusetts 02747
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North Dartmouth, MA
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Raleigh, North Carolina 27607
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Raleigh, NC
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San Antonio, Texas 78229
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San Antonio, TX
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San Diego, California 92123
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San Diego, CA
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