OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma

Dose Finding Study in Patients With Mild to Moderate Persistent Asthma: A Parallel Group, Randomised, Placebo Controlled, Double Blind Assessment of Oral Oc000459 Dosed At Three Dose Schedules for Twelve Weeks Finding Study In Patients With Mild To Moderate Persistent Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00890877

Enrollment

480

Registered

2009-04-30

Start date

2009-04-30

Completion date

2010-07-31

Last updated

2010-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Persistent Asthma

Keywords

asthma, treatment, placebo, efficacy, safety

Brief summary

This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.

Interventions

DRUGOC000459 or placebo

Pills, active and/or placebo given twice daily for 17 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception * Aged 18 to 55 years inclusive. * Non smokers for at least the past 12 months with a pack history of less than 10 pack years. * Mild to moderate persistent asthma according to GINA4 guidelines for at least 12 months

Exclusion criteria

* Receipt of prescribed or over the counter medication within 14 days prior to the first study day

Design outcomes

Primary

Measure	Time frame
Forced expiratory volume in one second (FEV1)	17 weeks

Secondary

Measure	Time frame
Asthma quality of life questionnaire (AQLQ)	17 weeks

Countries

Bulgaria, Hungary, Poland, Romania, Russia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026