Ragweed Allergy
Conditions
Keywords
Ragweed allergy
Brief summary
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.
Interventions
None listed
Sponsors
Quintiles, Inc.
Circassia Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily Combined Score during the site-specific ragweed pollen period | Daily during ragweed season expected to last approximately 8 weeks | Combined score is the Total Rhinoconjunctivitis Score(TRSS)/8 added to the Rescue Medication Score |
Secondary
| Measure | Time frame |
|---|---|
| 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 Combined 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 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 |
| 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 |
Countries
United States
Outcome results
None listed