Ragweed Observational Study

Study Overview
=================
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.

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

Conditions
-----------------
Ragweed Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ragweed allergic subjects<br> | |

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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ragweed allergy