Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

Oxagen Ltd15 sites in 1 country132 target enrollmentJanuary 2007

ConditionsAsthma

InterventionsOC000459 Placebo

DrugsOC000459 Placebo

Overview

Phase: Phase 2
Intervention: OC000459
Conditions: Asthma
Sponsor: Oxagen Ltd
Enrollment: 132
Locations: 15
Primary Endpoint: Forced expiratory volume in one second (FEV1)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

November 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oxagen Ltd

Eligibility Criteria

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.

Arms & Interventions

OC000459

Intervention: OC000459

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Forced expiratory volume in one second (FEV1)

Time Frame: 28 days

Secondary Outcomes

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)