Grass Observational Study

Launched by CIRCASSIA LIMITED · Feb 26, 2014

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • History of moderate to severe rhinoconjunctivitis consistent with allergy to grass for at least 2 years.
• • Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
• • Perennial Rye grass or Timothy grass-specific IgE ≥ 0.35 kU/L as measured by ImmunoCAP®.
• • Positive skin prick test to Perennial Rye grass or Timothy grass allergen
• Exclusion Criteria:
• • Positive skin prick test ≥ 5 mm to any confounding, co-existing seasonal allergens likely to be present during the pre-season baseline and grass pollen period.
• • Medical records of symptomatic perennial allergic rhinitis and/or asthma or a positive skin test ≥ 5 mm due to a perennial allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and which cannot be avoided during the course of the study.
• • Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
• • Subjects who had been treated with any non-grass licensed allergen immunotherapy extracts or non-grass investigational immunotherapy for more than 1 month within 1 year.