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

Phase 2
Completed
Conditions
Asthma
Interventions
Drug: Placebo
Registration Number
NCT01057927
Lead Sponsor
Oxagen Ltd
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
132
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
OC000459OC000459-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
Forced expiratory volume in one second (FEV1)28 days
Secondary Outcome Measures
NameTimeMethod
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 IgE28 days
Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters28 days

Trial Locations

Locations (15)

Sverdlovsk Regional Hospital #1

🇷🇺

Ekaterinburg, Russian Federation

Research Institute of Pulmonology

🇷🇺

Moscow, Russian Federation

Burdenko Main Military Hospital

🇷🇺

Moscow, Russian Federation

City Hospital #23

🇷🇺

Moscow, Russian Federation

City Hospital #7

🇷🇺

Moscow, Russian Federation

Vishnevsky Central Military Hospital #3

🇷🇺

Moscow, Russian Federation

Leningrad Regional Hospital

🇷🇺

St Petersbrug, Russian Federation

St George City Hospital

🇷🇺

St Petersburg, Russian Federation

St Petersburg Medical Academy of Postgraduate Education

🇷🇺

St Petersburg, Russian Federation

St Petersburg Medical Academy

🇷🇺

St Petersburg, Russian Federation

Scroll for more (5 remaining)
Sverdlovsk Regional Hospital #1
🇷🇺Ekaterinburg, Russian Federation

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