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

NCT01057927 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2010-01-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

OC000459

OC000459 capsules 2x100mg BID for 28 days

DRUG

Placebo

Placebo capsules to match OC000459 100mg capsules, 2 tablets BID

Sponsors & Collaborators

  • Oxagen Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01057927 on ClinicalTrials.gov