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

NCT01551147 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2013-04-30

No results posted yet for this study

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

Conditions

Interventions

DRUG

ONO-6950

200 mg QD for 8 days

DRUG

Placebo

Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner

DRUG

Montelukast

10 mg Montelukast QD for 8 days

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Ono Pharma USA Inc

    lead INDUSTRY

Principal Investigators

  • Ono Pharma USA, Inc. · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-04-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01551147 on ClinicalTrials.gov