A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients
This study has been completed.
Sponsor:
Ono Pharma USA Inc
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 28, 2013
Last verified: January 2013
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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
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 28, 2013 |
| 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 May 16, 2013