OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma
This study has been completed.
Sponsor:
Oxagen Ltd
Information provided by:
Oxagen Ltd
ClinicalTrials.gov Identifier:
NCT00890877
First received: April 29, 2009
Last updated: September 1, 2010
Last verified: September 2010
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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
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 May 19, 2013