OC000459 Bronchial Allergen Challenge

Launched by OXAGEN LTD · Jan 25, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.