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

September 1, 2010 updated by: Oxagen Ltd

Dose Finding Study in Patients With Mild to Moderate Persistent Asthma: A Parallel Group, Randomised, Placebo Controlled, Double Blind Assessment of Oral Oc000459 Dosed At Three Dose Schedules for Twelve Weeks Finding Study In Patients With Mild To Moderate Persistent Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks
Experimental: 2
Drug: OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks
Experimental: 3
Drug: OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks
Experimental: 4
Drug: OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced expiratory volume in one second (FEV1)
Time Frame: 17 weeks
17 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Asthma quality of life questionnaire (AQLQ)
Time Frame: 17 weeks
17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxagen Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 29, 2009

First Submitted That Met QC Criteria

April 29, 2009

First Posted (Estimate)

April 30, 2009

Study Record Updates

Last Update Posted (Estimate)

September 2, 2010

Last Update Submitted That Met QC Criteria

September 1, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC000459/012/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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