Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
This study has been completed.
Sponsor:
Oxagen Ltd
Information provided by:
Oxagen Ltd
ClinicalTrials.gov Identifier:
NCT01057927
First received: January 25, 2010
Last updated: January 27, 2010
Last verified: January 2010
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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 June 18, 2013