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

Oxagen

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: OC000459; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057927

OC000459/006/06

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria At Screening:

• Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
• Non smokers
• Mild to moderate asthmatics according to GINA guidelines for at least 12 months.
• History of asthma symptoms increasing in response to external allergens.
• Testing positive on skin prick test to an allergen associated with the subject's asthma

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups, including a placebo group

OC000459

Experimental group

Treatment:

Drug: OC000459

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo