OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma

NCT ID: NCT00890877

Last Updated: 2010-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-07-31

Brief Summary

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This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.

Detailed Description

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Conditions

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Mild to Moderate Persistent Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

OC000459 or placebo

Intervention Type DRUG

Pills, active and/or placebo given twice daily for 17 weeks

2

Group Type EXPERIMENTAL

OC000459 or placebo

Intervention Type DRUG

Pills, active and/or placebo given twice daily for 17 weeks

3

Group Type EXPERIMENTAL

OC000459 or placebo

Intervention Type DRUG

Pills, active and/or placebo given twice daily for 17 weeks

4

Group Type EXPERIMENTAL

OC000459 or placebo

Intervention Type DRUG

Pills, active and/or placebo given twice daily for 17 weeks

Interventions

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OC000459 or placebo

Pills, active and/or placebo given twice daily for 17 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
* Aged 18 to 55 years inclusive.
* Non smokers for at least the past 12 months with a pack history of less than 10 pack years.
* Mild to moderate persistent asthma according to GINA4 guidelines for at least 12 months

Exclusion Criteria

* Receipt of prescribed or over the counter medication within 14 days prior to the first study day
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxagen Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Oxagen Ltd

Locations

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Research site

Sofia, , Bulgaria

Site Status

Research site

Győr, , Hungary

Site Status

Research site

Warsaw, , Poland

Site Status

Research site

Bucharest, , Romania

Site Status

Research site

Moscow, , Russia

Site Status

Research site

Kiev, , Ukraine

Site Status

Countries

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Bulgaria Hungary Poland Romania Russia Ukraine

Other Identifiers

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OC000459/012/08

Identifier Type: -

Identifier Source: org_study_id

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