NCT01056692

Brief Summary

OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic response in the lungs, namely cat hair, pollen or house dust mite and methacholine.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

2 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

February 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
Last Updated

January 26, 2010

Status Verified

January 1, 2010

First QC Date

December 21, 2009

Last Update Submit

January 25, 2010

Conditions

Bronchial Asthma

Keywords

Asthmabronchial allergen challengesputum eosinophiilia

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 3 and 10 hours after allergen challenge.

    Primary outcome is measured after 15 days of treatment with active or placebo

Secondary Outcomes (1)

  • Secondary biological activity endpoints include the diminution of the early asthmatic response to bronchial allergen challenge sputum eosinophilia, the methacholine PC20 after allergen challenge and exhaled NO pre- and post-allergen.

    These measures are examined after 15 days of treatment with either active or placebo

Study Arms (2)

Active compound

ACTIVE COMPARATOR

OC000459 orally

Drug: OC000459

Placebo

PLACEBO COMPARATOR

Placebo given orally

Drug: Placebo

Interventions

OC000459DRUG

Capsules twice daily for 15 days

Active compound
PlaceboDRUG

Capsules twice daily for 15 days

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
  • FEV1 \>65% of predicted on at least two occasions at screening.
  • At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
  • No steroid usage in the past 12 weeks.
  • Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
  • Non smokers for a minimum of 6 months; less than 10 pack year history.

You may not qualify if:

  • Respiratory tract pathology other than allergic asthma.
  • Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
  • Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King's College London School of Medicine

London, London, SE5 9PJ, United Kingdom

Location

Medicines Evaluation Unit

Manchester, Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

  • Singh D, Cadden P, Hunter M, Pearce Collins L, Perkins M, Pettipher R, Townsend E, Vinall S, O'Connor B. Inhibition of the asthmatic allergen challenge response by the CRTH2 antagonist OC000459. Eur Respir J. 2013 Jan;41(1):46-52. doi: 10.1183/09031936.00092111. Epub 2012 Apr 10.

    PMID: 22496329DERIVED

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 Officials

  • David Singh, MD

    Medicines Evaluation Unit, Manchester, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2009

First Posted

January 26, 2010

Study Start

February 1, 2006

Last Updated

January 26, 2010

Record last verified: 2010-01

Locations

GB(2)