Ragweed Observational Study

Completed

Conditions studied: Ragweed Allergy

In brief

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.

Key facts

Study ID

NCT01398137

Run by

Circassia Limited

People needed

90

Starts

2011-07-01

Expected to finish

2011-10-01

Last updated by the study team

2011-10-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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