Ragweed Observational Study

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

This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue medication usage (as measured by Rescue Medication Score as a Combined Score to inform the design of a phase III field study with ToleroMune Ragweed.

Study Overview

• Status: Completed
• Conditions: Ragweed Allergy

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Owensboro, Kentucky, United States
  • Minnesota
    • Minneapolis, Minnesota, United States
    • Plymouth, Minnesota, United States
  • Missouri
    • Rolla, Missouri, United States
    • St Louis, Missouri, United States
    • Warrensburg, Missouri, United States
  • North Carolina
    • High Point, North Carolina, United States
  • Ohio
    • Canton, Ohio, United States
  • Virginia
    • Springfield, Virginia, United States
  • Wisconsin
    • Greenfield, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a history of ragweed allergy for at least 2 years and which required symptomatic treatment for at least 1 year

Description

Inclusion Criteria

• Male or female, aged 18-65 years.
• Reliable history of rhinoconjunctivitis and/or rhinoconjunctivitis plus controlled asthma on exposure to ragweed allergen for at least 2 years and required symptomatic treatment for at least 1 year.
• Positive skin prick test (SPT) to Ambrosia artemisiifolia
• Specific Immunoglobulin E (IgE) against Ambrosia artemisiifolia >0.35 kU/L

Exclusion Criteria

• Positive skin test to any confounding, co-existing seasonal allergens likely to be present during the Pre-season baseline and ragweed pollen periods (grasses, miscellaneous weeds, fall trees) and who have received medication for these confounding seasonal allergies.
• Medical records of symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and have received medication for these perennial allergies
• Subjects with a history of severe drug allergy, severe angioedema or anaphylactic reaction to food or previous SPT for any allergen.
• Subjects with a history of any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, immunopathological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may influence the subject's ability to participate in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ragweed allergic subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean daily Combined Score during the site-specific ragweed pollen period	Combined score is the Total Rhinoconjunctivitis Score(TRSS)/8 added to the Rescue Medication Score	Daily during ragweed season expected to last approximately 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean Combined Score during the site-specific peak ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean TRSS during the site-specific ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean TRSS during the site-specific peak ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rescue Medication Score during the site-specific ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rescue Medication Score during the site-specific peak ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean component scores of the TRSS (nasal and non nasal) during the site specific ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean component scores of the TRSS (nasal and non nasal) during the site specific peak ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score during the site specific peak ragweed pollen period in a subset of the study population	Through 2011 ragweed season approximately 8 weeks
Weeks of partly controlled or uncontrolled asthma	Through 2011 ragweed season expected to last approximately 8 weeks

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): October 27, 2011
• Last Update Submitted That Met QC Criteria: October 26, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Ragweed allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: TR003