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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental 200 mg dose

Group Type EXPERIMENTAL

ONO-6950

Intervention Type DRUG

200 mg QD, single dose

Experimental 20 mg dose

Group Type EXPERIMENTAL

ONO-6950

Intervention Type DRUG

20 mg QD, single dose

Active Comparator Montelukast

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

10 mg Montelukast, QD single dose

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner

Interventions

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ONO-6950

200 mg QD, single dose

Intervention Type DRUG

ONO-6950

20 mg QD, single dose

Intervention Type DRUG

Montelukast

10 mg Montelukast, QD single dose

Intervention Type DRUG

Placebo

Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No