Grass Observational Study

NCT02075138 | Completed

• 1 other identifier: TG003
• Study Type: observational
• Target: 109
• Locations: 3 countries
• Sites: 7

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.

Conditions

Grass Allergy; Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score

  6 weeks

Study Arms (1)

Grass-Induced Rhinoconjunctivitis Subjects

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a history of Grass induced Rhinoconjunctivitis

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Circassia Limited: lead
• Syneos Health: collaborator
• CIDAL: collaborator

Study Sites (7)

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Normal, Illinois, United States

Location

Unknown Facility

Sylvania, Ohio, United States

Location

Unknown Facility

Medford, Oregon, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

Unknown Facility

Buenos Aires City, Buenos Aires, Argentina

Location

Unknown Facility

Temuco, Región de la Araucanía, Chile

Location

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: March 3, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

US (5); CL (1); AR (1)