A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients
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
1 other identifier
interventional
59
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
February 20, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedFebruary 14, 2014
January 1, 2014
8 months
February 15, 2012
January 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise
60 minutes following the exercise challenge
Secondary Outcomes (5)
AUC (0-30 min)
30 minutes following the exercise challenge
AUC (0-60 min)
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
Study Arms (4)
Experimental 200 mg dose
EXPERIMENTALExperimental 20 mg dose
EXPERIMENTALActive Comparator Montelukast
ACTIVE COMPARATORPlacebo Comparator
PLACEBO COMPARATORInterventions
Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ono Pharma USA Inclead
- Ono Pharmaceutical Co. Ltdcollaborator
Study Sites (9)
Los Angeles Clinical Site 110
Los Angeles, California, 90025, United States
San Diego Clinical Site 140
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ono Pharma USA, Inc.
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
February 20, 2012
Study Start
March 1, 2012
Primary Completion
November 1, 2012
Last Updated
February 14, 2014
Record last verified: 2014-01