NCT01057927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
Last Updated

January 28, 2010

Status Verified

January 1, 2010

Enrollment Period

10 months

First QC Date

January 25, 2010

Last Update Submit

January 27, 2010

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Forced expiratory volume in one second (FEV1)

    28 days

Secondary Outcomes (3)

  • Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))

    28 days

  • Sputum eosinophilia (subset of patients) and serum IgE

    28 days

  • Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters

    28 days

Study Arms (2)

OC000459

EXPERIMENTAL
Drug: OC000459

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OC000459DRUG

OC000459 capsules 2x100mg BID for 28 days

OC000459
PlaceboDRUG

Placebo capsules to match OC000459 100mg capsules, 2 tablets BID

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Research Institute of Pulmonology

Moscow, 105077, Russia

Location

Burdenko Main Military Hospital

Moscow, 105229, Russia

Location

City Hospital #23

Moscow, 109240, Russia

Location

City Hospital #7

Moscow, 115446, Russia

Location

Vishnevsky Central Military Hospital #3

Moscow, 194354, Russia

Location

Leningrad Regional Hospital

Saint Petersbrug, 194291, Russia

Location

St George City Hospital

Saint Petersbrug, 194354, Russia

Location

St Petersburg Medical Academy of Postgraduate Education

Saint Petersburg, 190068, Russia

Location

St Petersburg Medical Academy

Saint Petersburg, 190068, Russia

Location

Outpatient Clinic #94

Saint Petersburg, 193231, Russia

Location

St Petersbrug Hospital of the Russian Academy of Science

Saint Petersburg, 194017, Russia

Location

Russian Center of Emergency and Radiology Medicine

Saint Petersburg, 194044, Russia

Location

St Petersburg State Pediatrics Academy

Saint Petersburg, 194100, Russia

Location

Central Medical Unit #122

Saint Petersburg, 194291, Russia

Location

St George City Hospital

Saint Petersburg, 194354, Russia

Location

Sverdlovsk Regional Hospital #1

Yekaterinburg, 620102, Russia

Location

Related Publications (1)

  • 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.

    PMID: 21762224DERIVED

MeSH Terms

Conditions

Asthma

Interventions

(5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 28, 2010

Study Start

January 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

January 28, 2010

Record last verified: 2010-01

Locations

RU(16)