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

This study has been completed.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01536041
First received: February 15, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: ONO-6950
Drug: Montelukast
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise [ Time Frame: 60 minutes following the exercise challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC (0-30 min) [ Time Frame: 30 minutes following the exercise challenge ] [ Designated as safety issue: No ]
    area under the concentration time curve integrating fall in FEV1 following exercise over the 30 minute interval immediately following exercise

  • AUC (0-60 min) [ Time Frame: 60 minutes following the exercise challenge ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 minutes following the exercise challenge ] [ Designated as safety issue: No ]
  • Proportion of patients using a short acting beta agonist (rescue medication) [ Time Frame: 90 minutes following the exercise challenge ] [ Designated as safety issue: No ]
  • Ratio of responder/non-responder in FEV1 [ Time Frame: 60 minutes following the exercise challenge ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: March 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 200 mg dose Drug: ONO-6950
200 mg QD, single dose
Experimental: Experimental 20 mg dose Drug: ONO-6950
20 mg QD, single dose
Active Comparator: Active Comparator Montelukast Drug: Montelukast
10 mg Montelukast, QD single dose
Placebo Comparator: Placebo Comparator Drug: Placebo
Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536041

Locations
United States, California
Los Angeles Clinical Site 110
Los Angeles, California, United States, 90025
San Diego Clinical Site 140
San Diego, California, United States, 92123
United States, Colorado
Denver Clinical Site 160
Denver, Colorado, United States, 80230
United States, Massachusetts
North Dartmouth Clincial Site 150
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Minneapolis Clinical Site 190
Minneapolis, Minnesota, United States, 55402
United States, New Jersey
Princeton Clinical Site 170
Princeton, New Jersey, United States, 08558
United States, North Carolina
Raleigh Clinical Site 130
Raleigh, North Carolina, United States, 27607
United States, Texas
New Braunfeis Clinical Site 120
New Braunfels, Texas, United States, 78130
San Antonio Clinical Site 180
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Ono Pharma USA Inc
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT01536041     History of Changes
Other Study ID Numbers: ONO-6950POU006
Study First Received: February 15, 2012
Last Updated: January 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ono Pharmaceutical Co. Ltd:
asthma
Adult

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014