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

Mild to Moderate Persistent Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890877
• Other study ID #: OC000459/012/08
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2009
• Last updated: September 1, 2010
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Oxagen Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationUkraine: Ministry of HealthHungary: National Institute of PharmacyBulgaria: Bulgarian Drug AgencyRomania: National Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma
• Mild to Moderate Persistent Asthma

Intervention

Drug:
• OC000459 or placebo
Pills, active and/or placebo given twice daily for 17 weeks

Locations

Country	Name	City	State
Bulgaria	Research site	Sofia
Hungary	Research site	Gyor
Poland	Research site	Warsaw
Romania	Research site	Bucharest
Russian Federation	Research site	Moscow
Ukraine	Research site	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Oxagen Ltd

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in one second (FEV1)		17 weeks	No
Secondary	Asthma quality of life questionnaire (AQLQ)		17 weeks	No