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

This study has been completed.
Sponsor:
Information provided by:
Oxagen Ltd
ClinicalTrials.gov Identifier:
NCT01057927
First received: January 25, 2010
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: OC000459
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

Resource links provided by NLM:


Further study details as provided by Oxagen Ltd:

Primary Outcome Measures:
  • Forced expiratory volume in one second (FEV1) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Sputum eosinophilia (subset of patients) and serum IgE [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 132
Study Start Date: January 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OC000459 Drug: OC000459
OC000459 capsules 2x100mg BID for 28 days
Placebo Comparator: Placebo Drug: Placebo
Placebo capsules to match OC000459 100mg capsules, 2 tablets BID

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057927

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

No publications provided by Oxagen Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr C Mike Perkins, Oxagen Ltd
ClinicalTrials.gov Identifier: NCT01057927     History of Changes
Other Study ID Numbers: OC000459/006/06
Study First Received: January 25, 2010
Last Updated: January 27, 2010
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 14, 2014