Grass Observational Study



Status:Completed
Conditions:Allergy, Neurology, Ocular
Therapuetic Areas:Neurology, Ophthalmology, Otolaryngology
Healthy:No
Age Range:12 - 65
Updated:3/16/2015
Start Date:April 2014
End Date:March 2015
Contact:Carlos Caparros
Email:ccaparros@cidal.net
Phone:541143837647

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An Observational Multi-Centre Field Study to Assess Symptom Scores and Allergy Medication Usage in Subjects With a History of Grass-Induced Rhinoconjunctivitis

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.


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.
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