Rhinoconjunctivitis Clinical Trial
Official title:
An Optional One Year Follow-up Study to Evaluate the Continued Efficacy of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber.
Verified date | May 2012 |
Source | Circassia Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Observational |
Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August.
In the third National Health and Nutrition Examination Surveys54.3% of the population had
positive test responses to one or more allergens, with the prevalence for short ragweed
being 26.2%
The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis
symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing
visits and the post treatment challenge (PTC) visit in study TR002 approximately one year
after the start of treatment.
Status | Completed |
Enrollment | 109 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria - Previously randomised into study TR002 and completed all treatment visits and the PTC. Exclusion Criteria - History of asthma (a diagnosis of asthma in childhood may be allowed). - Subjects with an FEV1 <70% of predicted. - Subjects being treated with beta-blockers. - Developed a significant disease, disorder or inability to communicate, since completing study TR002 which, in the opinion of the Sponsor's medical representative, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Cetero Research | Mississauga | Ontario |
Lead Sponsor | Collaborator |
---|---|
Circassia Limited | Adiga Life Sciences, Inc., Cetero Research, San Antonio |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Rhinoconjunctivitis Symptom Score | 48-54 weeks after the start of treatment in TR002 | No | |
Secondary | Total nasal and non-nasal symptom scores | 48-54 weeks after the start of treatment in TR002 | No | |
Secondary | Change in Immunoglobulin A (IgA) | 50-56 weeks after the start of treatment in Tr002 | No | |
Secondary | Change in Immunoglobulin E (IgE) | 50-56 weeks after the start of treatment in Tr002 | No | |
Secondary | Change in Immunoglobulin G4 (IgG4) | 50-56 weeks after the start of treatment in Tr002 | No | |
Secondary | Adverse Events | 50-56 weeks after the start of treatment in TR002 | Yes |
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