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CompletedNCT01056692Updated Jan 26, 2010

OC000459 Bronchial Allergen Challenge

A Phase 2 interventional study of OC000459 and Placebo in Bronchial Asthma, sponsored by Oxagen Ltd. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2010-01-26.

Sponsored by Oxagen Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchial Asthma

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Keywords

  • Asthma
  • bronchial allergen challenge
  • sputum eosinophiilia
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 20 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Oxagen Ltd is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Active compound

    OC000459 orally

    Drug: OC000459

  • Placebo comparator
    Placebo

    Placebo given orally

    Drug: Placebo

Interventions

  • DrugOC000459

    Capsules twice daily for 15 days

  • DrugPlacebo

    Capsules twice daily for 15 days

06

What researchers measure

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.

    Time frame: 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.

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

07

Study locations

2 sites
  • King's College London School of Medicine
    London, SE5 9PJ, United Kingdom
  • Medicines Evaluation Unit
    Manchester, M23 9LT, United Kingdom
08

References and documents

Publications

  • 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. PubMed 22496329 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01056692
Lead sponsor
Oxagen Ltd
Collaborators
Medicines Evaluation Unit, Manchester, UK, King's College Hospital NHS Trust
First posted
Jan 26, 2010
Start date
Feb 2006
Last update
Jan 26, 2010

Study contacts

David Singh, MD
principal investigator · Medicines Evaluation Unit, Manchester, UK

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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