Grass Observational Study

Rhinoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075138
• Other study ID #: TG003
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: April 7, 2015
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Conjunctivitis
• Grass Allergy
• Rhinoconjunctivitis

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	CIDAL, INC Research

Countries where clinical trial is conducted

United States,  Argentina,  Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score		6 weeks	No