Asthma
Conditions
Keywords
asthma, Adult
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.
Interventions
DRUGONO-6950
200 mg QD, single dose
DRUGMontelukast
10 mg Montelukast, QD single dose
DRUGPlacebo
Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner
Sponsors
Ono Pharmaceutical Co. Ltd
Ono Pharma USA Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise | 60 minutes following the exercise challenge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC (0-30 min) | 30 minutes following the exercise challenge | area under the concentration time curve integrating fall in FEV1 following exercise over the 30 minute interval immediately following exercise |
| AUC (0-60 min) | 60 minutes following the exercise challenge | area under the concentration time curve integrating fall in FEV1 following exercise over the 60 minute interval immediately following exercise |
| 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 | — |
Countries
United States
Outcome results
None listed