Grass Observational Study

Circassia Pharmaceuticals

Status: Completed

Conditions: Rhinoconjunctivitis; Grass Allergy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02075138

TG003

Details and patient eligibility

About

Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis.

The purpose of the current study is to evaluate allergy symptoms and allergy medication in subjects with grass-related rhinoconjunctivitis.

Enrollment: 109 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

109 participants in 1 patient group

Grass-Induced Rhinoconjunctivitis Subjects