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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057927
• Other study ID #: OC000459/006/06
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2010
• Last updated: January 27, 2010
• Start date: January 2007
• Est. completion date: November 2007

Study information

• Verified date: January 2010
• Source: Oxagen Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• OC000459
OC000459 capsules 2x100mg BID for 28 days
• Placebo
Placebo capsules to match OC000459 100mg capsules, 2 tablets BID

Locations

Country	Name	City	State
Russian Federation	Sverdlovsk Regional Hospital #1	Ekaterinburg
Russian Federation	Burdenko Main Military Hospital	Moscow
Russian Federation	City Hospital #23	Moscow
Russian Federation	City Hospital #7	Moscow
Russian Federation	Research Institute of Pulmonology	Moscow
Russian Federation	Vishnevsky Central Military Hospital #3	Moscow
Russian Federation	Leningrad Regional Hospital	St Petersbrug
Russian Federation	St George City Hospital	St Petersbrug
Russian Federation	Central Medical Unit #122	St Petersburg
Russian Federation	Outpatient Clinic #94	St Petersburg
Russian Federation	Russian Center of Emergency and Radiology Medicine	St Petersburg
Russian Federation	St George City Hospital	St Petersburg
Russian Federation	St Petersbrug Hospital of the Russian Academy of Science	St Petersburg
Russian Federation	St Petersburg Medical Academy	St Petersburg
Russian Federation	St Petersburg Medical Academy of Postgraduate Education	St Petersburg
Russian Federation	St Petersburg State Pediatrics Academy	St Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Oxagen Ltd

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in one second (FEV1)		28 days	No
Secondary	Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))		28 days	No
Secondary	Sputum eosinophilia (subset of patients) and serum IgE		28 days	No
Secondary	Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters		28 days	Yes