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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551147
• Other study ID #: ONO-6950POU005
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2012
• Last updated: April 29, 2013
• Start date: June 2012

Study information

• Verified date: April 2013
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 ß 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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ONO-6950
200 mg QD for 8 days
• Placebo
Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner
• Montelukast
10 mg Montelukast QD for 8 days

Locations

Country	Name	City	State
Canada	Calgary Clinical Site 540	Alberta
Canada	Hamilton Clinical Site 550	Ontario
Canada	Quebec Clinical Site 510	Quebec City
Canada	Saskatoon Clinical Site 520	Saskatoon
Canada	Vancouver Clinical Site 530	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Ono Pharma USA Inc	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1		Day 7	No
Primary	Early Asthmatic Response as measured by the AUC in FEV1		Day 7	No
Primary	Late Asthmatic Response as measured by the Maximum Fall in FEV1		Day 7	No
Primary	Early Asthmatic Response as measured by the Maximum Fall in FEV1		Day 7	No
Secondary	Differences in PC20 pre-post treatment as measured by methacholine challenge		Day 6	No
Secondary	Differences in PC20 pre-post allergen challenge as measured by methacholine challenge		Day 8	No