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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: OC000459; 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

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-27
• Last Update Submitted: 2010-01-27
• Study First Posted: 2010-01-28
• Last Update Posted: 2010-01-28

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

Group	Intervention	Description
OC000459	OC000459	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in one second (FEV1)	28 days

Secondary Outcome Measures

Name	Time	Method
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
Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters	28 days

Trial Locations

Locations (15)

City Hospital #7; 🇷🇺 Moscow, Russian Federation

Sverdlovsk Regional Hospital #1; 🇷🇺 Ekaterinburg, Russian Federation

Research Institute of Pulmonology; 🇷🇺 Moscow, Russian Federation

St George City Hospital; 🇷🇺 St Petersburg, Russian Federation

Burdenko Main Military Hospital; 🇷🇺 Moscow, Russian Federation

City Hospital #23; 🇷🇺 Moscow, Russian Federation

Vishnevsky Central Military Hospital #3; 🇷🇺 Moscow, Russian Federation

Leningrad Regional Hospital; 🇷🇺 St Petersbrug, Russian Federation

St Petersburg Medical Academy of Postgraduate Education; 🇷🇺 St Petersburg, Russian Federation

St Petersburg Medical Academy; 🇷🇺 St Petersburg, Russian Federation

Outpatient Clinic #94; 🇷🇺 St Petersburg, Russian Federation

Russian Center of Emergency and Radiology Medicine; 🇷🇺 St Petersburg, Russian Federation

St Petersburg State Pediatrics Academy; 🇷🇺 St Petersburg, Russian Federation

Central Medical Unit #122; 🇷🇺 St Petersburg, Russian Federation

St Petersbrug Hospital of the Russian Academy of Science; 🇷🇺 St Petersburg, Russian Federation