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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ONO-6950
ONO-6950
Montelukast
Placebo
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, Adult

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Los Angeles Clinical Site 110
  • San Diego Clinical Site 140
  • Denver Clinical Site 160
  • North Dartmouth Clincial Site 150
  • Minneapolis Clinical Site 190
  • Princeton Clinical Site 170
  • Raleigh Clinical Site 130
  • New Braunfeis Clinical Site 120
  • San Antonio Clinical Site 180

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Experimental 200 mg dose

Experimental 20 mg dose

Active Comparator Montelukast

Placebo Comparator

Arm Description

Outcomes

Primary Outcome Measures

Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise

Secondary Outcome Measures

AUC (0-30 min)
area under the concentration time curve integrating fall in FEV1 following exercise over the 30 minute interval immediately following exercise
AUC (0-60 min)
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
Proportion of patients using a short acting beta agonist (rescue medication)
Ratio of responder/non-responder in FEV1

Full Information

First Posted
February 15, 2012
Last Updated
January 21, 2014
Sponsor
Ono Pharma USA Inc
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01536041
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental 200 mg dose
Arm Type
Experimental
Arm Title
Experimental 20 mg dose
Arm Type
Experimental
Arm Title
Active Comparator Montelukast
Arm Type
Active Comparator
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ONO-6950
Intervention Description
200 mg QD, single dose
Intervention Type
Drug
Intervention Name(s)
ONO-6950
Intervention Description
20 mg QD, single dose
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
10 mg Montelukast, QD single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner
Primary Outcome Measure Information:
Title
Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise
Time Frame
60 minutes following the exercise challenge
Secondary Outcome Measure Information:
Title
AUC (0-30 min)
Description
area under the concentration time curve integrating fall in FEV1 following exercise over the 30 minute interval immediately following exercise
Time Frame
30 minutes following the exercise challenge
Title
AUC (0-60 min)
Description
area under the concentration time curve integrating fall in FEV1 following exercise over the 60 minute interval immediately following exercise
Time Frame
60 minutes following the exercise challenge
Title
Time to recovery of FEV1 to within 5% of the pre-exercise baseline
Time Frame
90 minutes following the exercise challenge
Title
Proportion of patients using a short acting beta agonist (rescue medication)
Time Frame
90 minutes following the exercise challenge
Title
Ratio of responder/non-responder in FEV1
Time Frame
60 minutes following the exercise challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharma USA, Inc.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Los Angeles Clinical Site 110
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
San Diego Clinical Site 140
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Denver Clinical Site 160
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
North Dartmouth Clincial Site 150
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Minneapolis Clinical Site 190
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Princeton Clinical Site 170
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Raleigh Clinical Site 130
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
New Braunfeis Clinical Site 120
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
San Antonio Clinical Site 180
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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