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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
OC000459
Placebo
Sponsored by
Oxagen Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OC000459

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Forced expiratory volume in one second (FEV1)

Secondary Outcome Measures

Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))
Sputum eosinophilia (subset of patients) and serum IgE
Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters

Full Information

First Posted
January 25, 2010
Last Updated
January 27, 2010
Sponsor
Oxagen Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01057927
Brief Title
Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
Official Title
Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oxagen Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OC000459
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OC000459
Intervention Description
OC000459 capsules 2x100mg BID for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules to match OC000459 100mg capsules, 2 tablets BID
Primary Outcome Measure Information:
Title
Forced expiratory volume in one second (FEV1)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))
Time Frame
28 days
Title
Sputum eosinophilia (subset of patients) and serum IgE
Time Frame
28 days
Title
Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Sverdlovsk Regional Hospital #1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Research Institute of Pulmonology
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Burdenko Main Military Hospital
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
City Hospital #23
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
City Hospital #7
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Vishnevsky Central Military Hospital #3
City
Moscow
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Leningrad Regional Hospital
City
St Petersbrug
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
St George City Hospital
City
St Petersbrug
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
St Petersburg Medical Academy of Postgraduate Education
City
St Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
St Petersburg Medical Academy
City
St Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Outpatient Clinic #94
City
St Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Facility Name
St Petersbrug Hospital of the Russian Academy of Science
City
St Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Facility Name
Russian Center of Emergency and Radiology Medicine
City
St Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
St Petersburg State Pediatrics Academy
City
St Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Central Medical Unit #122
City
St Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
St George City Hospital
City
St Petersburg
ZIP/Postal Code
194354
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
21762224
Citation
Barnes N, Pavord I, Chuchalin A, Bell J, Hunter M, Lewis T, Parker D, Payton M, Collins LP, Pettipher R, Steiner J, Perkins CM. A randomized, double-blind, placebo-controlled study of the CRTH2 antagonist OC000459 in moderate persistent asthma. Clin Exp Allergy. 2012 Jan;42(1):38-48. doi: 10.1111/j.1365-2222.2011.03813.x. Epub 2011 Jul 15.
Results Reference
derived

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

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