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

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:
NCT01551147
First received: March 8, 2012
Last updated: April 29, 2013
Last verified: April 2013
  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 Intervention Phase
Asthma
Drug: ONO-6950
Drug: Placebo
Drug: Montelukast
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, 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

Resource links provided by NLM:


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

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 ]

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 ]

Enrollment: 25
Study Start Date: June 2012
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 200 mg dose Drug: ONO-6950
200 mg QD for 8 days
Active Comparator: Active Comparator Drug: Montelukast
10 mg Montelukast QD for 8 days
Placebo Comparator: Placebo Comparator Drug: Placebo
Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner

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.

  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 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
  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: NCT01551147

Locations
Canada, British Columbia
Vancouver Clinical Site 530
Vancouver, British Columbia, Canada, V6T2B5
Canada
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
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: NCT01551147     History of Changes
Other Study ID Numbers: ONO-6950POU005
Study First Received: March 8, 2012
Last Updated: April 29, 2013
Health Authority: Canada: Health Canada

Keywords provided by Ono Pharmaceutical Co. Ltd:
asthma
ONO-6950
asthma in adult patients

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

ClinicalTrials.gov processed this record on November 24, 2014