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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536041
• Other study ID #: ONO-6950POU006
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2012
• Last updated: January 21, 2014
• Start date: March 2012

Study information

• Verified date: January 2014
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 ß 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ONO-6950
200 mg QD, single dose
• ONO-6950
20 mg QD, single dose
• Montelukast
10 mg Montelukast, QD single dose
• Placebo
Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner

Locations

Country	Name	City	State
United States	Denver Clinical Site 160	Denver	Colorado
United States	Los Angeles Clinical Site 110	Los Angeles	California
United States	Minneapolis Clinical Site 190	Minneapolis	Minnesota
United States	New Braunfeis Clinical Site 120	New Braunfels	Texas
United States	North Dartmouth Clincial Site 150	North Dartmouth	Massachusetts
United States	Princeton Clinical Site 170	Princeton	New Jersey
United States	Raleigh Clinical Site 130	Raleigh	North Carolina
United States	San Antonio Clinical Site 180	San Antonio	Texas
United States	San Diego Clinical Site 140	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Ono Pharma USA Inc	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise		60 minutes following the exercise challenge	No
Secondary	AUC (0-30 min)	area under the concentration time curve integrating fall in FEV1 following exercise over the 30 minute interval immediately following exercise	30 minutes following the exercise challenge	No
Secondary	AUC (0-60 min)	area under the concentration time curve integrating fall in FEV1 following exercise over the 60 minute interval immediately following exercise	60 minutes following the exercise challenge	No
Secondary	Time to recovery of FEV1 to within 5% of the pre-exercise baseline		90 minutes following the exercise challenge	No
Secondary	Proportion of patients using a short acting beta agonist (rescue medication)		90 minutes following the exercise challenge	No
Secondary	Ratio of responder/non-responder in FEV1		60 minutes following the exercise challenge	No