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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ono Pharma USA Inc
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Montelukast

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