Dose Finding Study in Patients With Mild to Moderate Persistent Asthma - Full Text View

Sponsored by:	Oxagen Ltd
Information provided by:	Oxagen Ltd
ClinicalTrials.gov Identifier:	NCT00890877

Purpose

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.

Condition	Intervention	Phase
Mild to Moderate Persistent Asthma	Drug: OC000459 or placebo	Phase II

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Oxagen Ltd:

Primary Outcome Measures:

Forced expiratory volume in one second (FEV1) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Asthma quality of life questionnaire (AQLQ) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	480
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: OC000459 or placebo Pills, active and/or placebo given twice daily for 17 weeks
2: Experimental	Drug: OC000459 or placebo Pills, active and/or placebo given twice daily for 17 weeks
3: Experimental	Drug: OC000459 or placebo Pills, active and/or placebo given twice daily for 17 weeks
4: Experimental	Drug: OC000459 or placebo Pills, active and/or placebo given twice daily for 17 weeks

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 more 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890877

Contacts

Contact: Dany Azzi, MD

Dany.Azzi@psi-cro.com

Locations

Bulgaria
Research site	Not yet recruiting
Sofia, Bulgaria
Hungary
Research site	Not yet recruiting
Gyor, Hungary
Poland
Research site	Not yet recruiting
Warsaw, Poland
Romania
Research site	Not yet recruiting
Bucharest, Romania
Russian Federation
Research site	Recruiting
Moscow, Russian Federation
Ukraine
Research site	Not yet recruiting
Kiev, Ukraine

Sponsors and Collaborators

Oxagen Ltd

More Information

No publications provided

Responsible Party:	Oxagen Ltd ( Dr C Mike Perkins )
Study ID Numbers:	OC000459/012/08
Study First Received:	April 29, 2009
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00890877 History of Changes
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health; Hungary: National Institute of Pharmacy; Bulgaria: Bulgarian Drug Agency; Romania: National Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Oxagen Ltd:

asthma
treatment
placebo
efficacy
safety

Study placed in the following topic categories:

Signs and Symptoms
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009