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Completed

NCT Number: NCT01448902

A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Vienna Challenge Chamber

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

OC000459

Drug

OC000459 200mg bid for 8 days

Placebo

Drug

Placebo bid for 8 days

Primary outcomes

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

    Time frame: 8 days

    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

Secondary outcomes

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

    Time frame: 8 days

    To assess the safety of this treatment schedule in male subjects with allergic rhinitis as assessed via adverse events, clinical chemistry and haematology, FEV1 and vital signs.

  2. OC000459 plasma concentration (Cmin)

    Time frame: 8 days

    To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).

Sponsors and collaborators

Lead sponsor

Oxagen Ltd

Industry

Registry information

Official study title

A Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Oct 7, 2011
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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