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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: ONO-6950
* Drug: Placebo
* Drug: Montelukast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 200 mg dose<br> | Drug: ONO-6950<br>* 200 mg QD for 8 days<br>|
| Active Comparator: Active Comparator<br> | Drug: Montelukast<br>* 10 mg Montelukast QD for 8 days<br>|
| Placebo Comparator: Placebo Comparator<br> | Drug: Placebo<br>* Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1 |  | Day 7 | 
| Early Asthmatic Response as measured by the AUC in FEV1 |  | Day 7 | 
| Late Asthmatic Response as measured by the Maximum Fall in FEV1 |  | Day 7 | 
| Early Asthmatic Response as measured by the Maximum Fall in FEV1 |  | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in PC20 pre-post treatment as measured by methacholine challenge |  | Day 6 | 
| Differences in PC20 pre-post allergen challenge as measured by methacholine challenge |  | Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, ONO-6950, asthma in adult patients