Grass Observational Study

Completed

• Conditions: Grass Allergy; Rhinoconjunctivitis

• Registration Number: NCT02075138
• Lead Sponsor: Circassia Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-03-03
• Study Start: 2014-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score	6 weeks