Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

January 27, 2010 updated by: Oxagen Ltd

Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

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

  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
        • Sverdlovsk Regional Hospital #1
      • Moscow, Russian Federation, 105077
        • Research Institute of Pulmonology
      • Moscow, Russian Federation, 105229
        • Burdenko Main Military Hospital
      • Moscow, Russian Federation, 109240
        • City Hospital #23
      • Moscow, Russian Federation, 115446
        • City Hospital #7
      • Moscow, Russian Federation, 194354
        • Vishnevsky Central Military Hospital #3
      • St Petersbrug, Russian Federation, 194291
        • Leningrad Regional Hospital
      • St Petersbrug, Russian Federation, 194354
        • St George City Hospital
      • St Petersburg, Russian Federation, 190068
        • St Petersburg Medical Academy of Postgraduate Education
      • St Petersburg, Russian Federation, 190068
        • St Petersburg Medical Academy
      • St Petersburg, Russian Federation, 193231
        • Outpatient Clinic #94
      • St Petersburg, Russian Federation, 194017
        • St Petersbrug Hospital of the Russian Academy of Science
      • St Petersburg, Russian Federation, 194044
        • Russian Center of Emergency and Radiology Medicine
      • St Petersburg, Russian Federation, 194100
        • St Petersburg State Pediatrics Academy
      • St Petersburg, Russian Federation, 194291
        • Central Medical Unit #122
      • St Petersburg, Russian Federation, 194354
        • St George City Hospital

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 At Screening:

  • Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
  • Non smokers
  • Mild to moderate asthmatics according to GINA guidelines for at least 12 months.
  • History of asthma symptoms increasing in response to external allergens.
  • Testing positive on skin prick test to an allergen associated with the subject's asthma

Exclusion Criteria:

  • Use of inhaled or local corticosteroids in the period from 28 days prior to screening.
  • Receipt of prescribed or over the counter medication within 14 days of 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo capsules to match OC000459 100mg capsules, 2 tablets BID
Experimental: OC000459
Drug: OC000459
OC000459 capsules 2x100mg BID for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced expiratory volume in one second (FEV1)
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))
Time Frame: 28 days
28 days
Sputum eosinophilia (subset of patients) and serum IgE
Time Frame: 28 days
28 days
Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters
Time Frame: 28 days
28 days

Collaborators and Investigators

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

Sponsor

Oxagen Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

January 28, 2010

Last Update Submitted That Met QC Criteria

January 27, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC000459/006/06

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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