Status:
COMPLETED
Ragweed Observational Study
Lead Sponsor:
Circassia Limited
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Ragweed Allergy
Eligibility:
All Genders
18-65 years
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01398137
Start Date
July 1 2011
End Date
October 1 2011
Last Update
October 27 2011
Active Locations (10)
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1
Owensboro, Kentucky, United States
2
Minneapolis, Minnesota, United States
3
Plymouth, Minnesota, United States
4
Rolla, Missouri, United States