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

This study has been completed.
Sponsor:
Information provided by:
Oxagen Ltd
ClinicalTrials.gov Identifier:
NCT00890877
First received: April 29, 2009
Last updated: September 1, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Mild to Moderate Persistent Asthma
Drug: OC000459 or placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

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: 17 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma quality of life questionnaire (AQLQ) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890877

Locations
Bulgaria
Research site
Sofia, Bulgaria
Hungary
Research site
Gyor, Hungary
Poland
Research site
Warsaw, Poland
Romania
Research site
Bucharest, Romania
Russian Federation
Research site
Moscow, Russian Federation
Ukraine
Research site
Kiev, Ukraine
Sponsors and Collaborators
Oxagen Ltd
  More Information

No publications provided

Responsible Party: Dr C Mike Perkins, Oxagen Ltd
ClinicalTrials.gov Identifier: NCT00890877     History of Changes
Other Study ID Numbers: OC000459/012/08
Study First Received: April 29, 2009
Last Updated: September 1, 2010
Health Authority: Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Hungary: National Institute of Pharmacy
Bulgaria: Bulgarian Drug Agency
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Oxagen Ltd:
asthma
treatment
placebo
efficacy
safety

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 September 18, 2014