Clinical trial NCT01536041: A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
Adult
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2012-02-20
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise
timeFrame: 60 minutes following the exercise challenge
Secondary outcomes:
measure: AUC (0-30 min)
timeFrame: 30 minutes following the exercise challenge
measure: AUC (0-60 min)
timeFrame: 60 minutes following the exercise challenge
measure: Time to recovery of FEV1 to within 5% of the pre-exercise baseline
timeFrame: 90 minutes following the exercise challenge
measure: Proportion of patients using a short acting beta agonist (rescue medication)
timeFrame: 90 minutes following the exercise challenge
measure: Ratio of responder/non-responder in FEV1
timeFrame: 60 minutes following the exercise challenge
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Clinical Site 110
state: California
city: San Diego
country: United States
facility: San Diego Clinical Site 140
state: California
city: Denver
country: United States
facility: Denver Clinical Site 160
state: Colorado
city: North Dartmouth
country: United States
facility: North Dartmouth Clincial Site 150
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Clinical Site 190
state: Minnesota
city: Princeton
country: United States
facility: Princeton Clinical Site 170
state: New Jersey
city: Raleigh
country: United States
facility: Raleigh Clinical Site 130
state: North Carolina
city: New Braunfels
country: United States
facility: New Braunfeis Clinical Site 120
state: Texas
city: San Antonio
country: United States
facility: San Antonio Clinical Site 180
state: Texas
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References: