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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Mild to Moderate Persistent Asthma

Intervention / Treatment
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* Drug: OC000459 or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: OC000459 or placebo<br>* Pills, active and/or placebo given twice daily for 17 weeks<br>|
| Experimental: 2<br> | Drug: OC000459 or placebo<br>* Pills, active and/or placebo given twice daily for 17 weeks<br>|
| Experimental: 3<br> | Drug: OC000459 or placebo<br>* Pills, active and/or placebo given twice daily for 17 weeks<br>|
| Experimental: 4<br> | Drug: OC000459 or placebo<br>* Pills, active and/or placebo given twice daily for 17 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in one second (FEV1) |  | 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma quality of life questionnaire (AQLQ) |  | 17 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, treatment, placebo, efficacy, safety