A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma | RxWiki

A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma

Overview[ - collapse ][ - ]

Purpose	The primary objectives are - to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled allergen - to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days in patients with asthma The secondary objectives are: - to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1 following allergen exposure, and - to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced airway hyperresponsiveness (AHR) as measured by methacholine challenge
Condition	Asthma
Intervention	Drug: ONO-6950 Drug: Placebo Drug: Montelukast
Phase	Phase 2
Sponsor	Ono Pharma USA Inc
Responsible Party	Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier	NCT01551147
First Received	March 8, 2012
Last Updated	April 29, 2013
Last verified	April 2013

Tracking Information[ + expand ][ + ]

First Received Date	March 8, 2012
Last Updated Date	April 29, 2013
Start Date	June 2012
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1 [Time Frame: Day 7] [Designated as safety issue: No] Early Asthmatic Response as measured by the AUC in FEV1 [Time Frame: Day 7] [Designated as safety issue: No] Late Asthmatic Response as measured by the Maximum Fall in FEV1 [Time Frame: Day 7] [Designated as safety issue: No] Early Asthmatic Response as measured by the Maximum Fall in FEV1 [Time Frame: Day 7] [Designated as safety issue: No]
Current Secondary Outcome Measures	Differences in PC20 pre-post treatment as measured by methacholine challenge [Time Frame: Day 6] [Designated as safety issue: No] Differences in PC20 pre-post allergen challenge as measured by methacholine challenge [Time Frame: Day 8] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma
Official Title	A Double-blind, Placebo-controlled, Three-way Crossover Study to Compare the Safety and Efficacy of 8 Days of Therapy With ONO-6950 Versus Placebo and Montelukast (Singulair®) on Asthmatic Responses and Airway Hypersensitivity Following Allergen Challenge in Patients With Asthma
Brief Summary	The primary objectives are - to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled allergen - to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days in patients with asthma The secondary objectives are: - to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1 following allergen exposure, and - to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced airway hyperresponsiveness (AHR) as measured by methacholine challenge
Detailed Description	The study will examine if ONO-6950 could alleviate EAR and LAR caused by an allergen challenge in subjects with asthma. Patients will be required to have EAR and LAR after standardized allergen challenges during the screening. Eligible patients will complete a randomized, double-blind, three-way crossover study. During each of three evaluation periods, patients will be administered either 200 mg ONO-6950, 10 mg Montelukast, or placebo for 8 days. Each evaluation period will occur over 8 days and will include various assessments following allergen challenge and methacholine challenge. The study does not require an overnight stay at the clinical research center.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Asthma
Intervention	Drug: ONO-6950 200 mg QD for 8 days Drug: Placebo Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner Drug: Montelukast 10 mg Montelukast QD for 8 days
Study Arm (s)	Experimental: Experimental 200 mg dose Active Comparator: Active Comparator Placebo Comparator: Placebo Comparator

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	25
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	April 2013
Eligibility Criteria	Inclusion Criteria: - Patients of both genders, between 18 to 60 years of age, with bronchial asthma symptoms for at least 6 months - Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing - Screening allergen challenge demonstrates that the patient experiences both an early and late asthmatic response - Sensitivity to methacholine resulting in a ≥ 20% fall in FEV1 (PC20 methacholine) - 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 - 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 - Significant safety laboratory, ECG, or vital sign abnormalities that would place the patient at undue disk during the study procedures - History of clinically significant multiple drug or food allergy
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Canada

Administrative Information[ + expand ][ + ]

NCT Number	NCT01551147
Other Study ID Numbers	ONO-6950POU005
Has Data Monitoring Committee	No
Information Provided By	Ono Pharmaceutical Co. Ltd
Study Sponsor	Ono Pharma USA Inc
Collaborators	Ono Pharmaceutical Co. Ltd
Investigators	Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
Verification Date	April 2013

Locations[ + expand ][ + ]

Vancouver Clinical Site 530	Vancouver, British Columbia, Canada, V6T2B5
Calgary Clinical Site 540	Alberta, Canada, T2N4N1
Hamilton Clinical Site 550	Ontario, Canada, L8N3Z5
Quebec Clinical Site 510	Quebec City, Canada, G1V4GS
Saskatoon Clinical Site 520	Saskatoon, Canada, S7N0W8