OC000459 Bronchial Allergen Challenge

Oxagen Ltd20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bronchial Asthma

Interventions

OC000459DRUG

Capsules twice daily for 15 days

PlaceboDRUG

Capsules twice daily for 15 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (2)

King's College London School of Medicine

London, London, United Kingdom

Medicines Evaluation Unit

Manchester, Manchester, United Kingdom

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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