- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02075138
Grass Observational Study
April 7, 2015 updated by: Circassia Limited
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
109
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires
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Buenos Aires City, Buenos Aires, Argentina
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Araucanía
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Temuco, Araucanía, Chile
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District of Columbia
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Washington, District of Columbia, United States
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Illinois
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Normal, Illinois, United States
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Ohio
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Sylvania, Ohio, United States
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Oregon
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Medford, Oregon, United States
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Washington
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Spokane, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with a history of Grass induced Rhinoconjunctivitis
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Grass-Induced Rhinoconjunctivitis Subjects
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score
Time Frame: 6 weeks
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
February 20, 2014
First Submitted That Met QC Criteria
February 26, 2014
First Posted (Estimate)
March 3, 2014
Study Record Updates
Last Update Posted (Estimate)
April 8, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TG003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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