Asthma
Conditions
Brief summary
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.
Interventions
DRUGOC000459
OC000459 capsules 2x100mg BID for 28 days
DRUGPlacebo
Placebo capsules to match OC000459 100mg capsules, 2 tablets BID
Sponsors
Oxagen Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced expiratory volume in one second (FEV1) | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters | 28 days |
| Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S)) | 28 days |
| Sputum eosinophilia (subset of patients) and serum IgE | 28 days |
Countries
Russia
Outcome results
None listed