OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma
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
1 other identifier
interventional
480
6 countries
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2009
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 29, 2009
CompletedFirst Posted
Study publicly available on registry
April 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedSeptember 2, 2010
September 1, 2010
1.1 years
April 29, 2009
September 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced expiratory volume in one second (FEV1)
17 weeks
Secondary Outcomes (1)
Asthma quality of life questionnaire (AQLQ)
17 weeks
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Receipt of prescribed or over the counter medication within 14 days prior to the first study day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oxagen Ltdlead
Study Sites (6)
Research site
Sofia, Bulgaria
Research site
Győr, Hungary
Research site
Warsaw, Poland
Research site
Bucharest, Romania
Research site
Moscow, Russia
Research site
Kiev, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 29, 2009
First Posted
April 30, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2010
Study Completion
July 1, 2010
Last Updated
September 2, 2010
Record last verified: 2010-09