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

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

    • Buenos Aires
      • Buenos Aires City, Buenos Aires, Argentina
    • Araucanía
      • Temuco, Araucanía, Chile
    • District of Columbia
      • Washington, District of Columbia, United States
    • Illinois
      • Normal, Illinois, United States
    • Ohio
      • Sylvania, Ohio, United States
    • Oregon
      • Medford, Oregon, United States
    • Washington
      • Spokane, Washington, United States

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
Grass-Induced Rhinoconjunctivitis Subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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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