NCT01448902

Brief Summary

The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a randomised, double blind, placebo controlled, two way crossover evaluation. There will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. There will be a follow up one to three weeks after the last dose of study drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

2 months

First QC Date

July 27, 2011

Last Update Submit

October 6, 2011

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitisCRTH2

Outcome Measures

Primary Outcomes (1)

  • Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score

    To assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours as shown by the effect on Total Nasal Symptom Score

    8 days

Secondary Outcomes (2)

  • OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs

    8 days

  • OC000459 plasma concentration (Cmin)

    8 days

Study Arms (2)

OC000459

EXPERIMENTAL
Drug: OC000459

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OC000459DRUG

OC000459 200mg bid for 8 days

OC000459
PlaceboDRUG

Placebo bid for 8 days

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
  • Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
  • FEV1 within normal limits (≥90% of predicted).
  • Atopy defined by a positive cutaneous response to mixed grass pollen within the last 12 months or at screening.
  • Asymptomatic at screening
  • Non smokers for at least the past 12 months

You may not qualify if:

  • Medical conditions likely to affect the outcome of the study.
  • Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.
  • Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function
  • Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Challenge Chamber

Vienna, Austria

Location

Related Publications (1)

  • Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Collins LP, Hunter MG, Steiner J, Lewis T, Payton MA, Perkins CM, Pettipher R. The CRTH2 antagonist OC000459 reduces nasal and ocular symptoms in allergic subjects exposed to grass pollen, a randomised, placebo-controlled, double-blind trial. Allergy. 2012 Dec;67(12):1572-9. doi: 10.1111/all.12042. Epub 2012 Oct 1.

    PMID: 23025511DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

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

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Friedrich Horak, Prof Dr

    Vienna Challenge Chamber

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2011

First Posted

October 7, 2011

Study Start

March 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations

AU(1)