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NCT Number: NCT01056692

OC000459 Bronchial Allergen Challenge

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.

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Key information

Conditions

Bronchial Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

King's College London School of Medicine, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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.

Treatment and study plan

OC000459

Drug

Capsules twice daily for 15 days

Placebo

Drug

Capsules twice daily for 15 days

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

Sponsors and collaborators

Lead sponsor

Oxagen Ltd

Industry

Collaborators

  • King's College Hospital NHS Trust
  • Medicines Evaluation Unit, Manchester, UK

Registry information

Official study title

A Phase II Study of oc000459 in Subjects With Allergic Asthma; a Randomised, Double Blind, Two Way Balanced Crossover Comparing oc000459 With Placebo

Important dates

Study start
2006
First posted
Jan 26, 2010
Registry last updated
Jan 26, 2010

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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