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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01536041

Run by

Ono Pharma USA Inc

People needed

59

Starts

2012-03-01

Last updated by the study team

2014-02-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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