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

Ono Pharma USA Inc25 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (5)

Vancouver Clinical Site 530

Vancouver, British Columbia, Canada

Calgary Clinical Site 540

Alberta, Canada

Hamilton Clinical Site 550

Ontario, Canada

Quebec Clinical Site 510

Québec, Canada

Saskatoon Clinical Site 520

Saskatoon, Canada

Outcomes

Primary Outcomes

Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1

Time frame: Day 7

Early Asthmatic Response as measured by the AUC in FEV1

Time frame: Day 7

Late Asthmatic Response as measured by the Maximum Fall in FEV1

Time frame: Day 7

Early Asthmatic Response as measured by the Maximum Fall in FEV1

Time frame: Day 7

Secondary Outcomes

Differences in PC20 pre-post treatment as measured by methacholine challenge

Time frame: Day 6

Differences in PC20 pre-post allergen challenge as measured by methacholine challenge

Time frame: Day 8

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

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes