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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: ONO-6950; Drug: Placebo; Drug: Montelukast

• Registration Number: NCT01536041
• Lead Sponsor: Ono Pharma USA Inc

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.

Study Timeline

• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-20
• Study Start: 2012-03
• Primary Completion: 2012-11
• Status Verified: 2014-01
• Disposition First Submitted: 2014-01-21
• Disposition First Submitted QC: 2014-01-21
• Last Update Submitted: 2014-01-21
• Disposition First Posted: 2014-02-14
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental 200 mg dose	ONO-6950	-
Experimental 20 mg dose	ONO-6950	-
Placebo Comparator	Placebo	-
Active Comparator Montelukast	Montelukast	-

Primary Outcome Measures

Name	Time	Method
Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise	60 minutes following the exercise challenge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Raleigh Clinical Site 130; 🇺🇸 Raleigh, North Carolina, United States

Denver Clinical Site 160; 🇺🇸 Denver, Colorado, United States

San Diego Clinical Site 140; 🇺🇸 San Diego, California, United States

Los Angeles Clinical Site 110; 🇺🇸 Los Angeles, California, United States

North Dartmouth Clincial Site 150; 🇺🇸 North Dartmouth, Massachusetts, United States

Princeton Clinical Site 170; 🇺🇸 Princeton, New Jersey, United States

New Braunfeis Clinical Site 120; 🇺🇸 New Braunfels, Texas, United States

Minneapolis Clinical Site 190; 🇺🇸 Minneapolis, Minnesota, United States

San Antonio Clinical Site 180; 🇺🇸 San Antonio, Texas, United States