Ragweed Allergy, Rhinoconjunctivitis
Conditions
Keywords
Ragweed Allergy, Rhinoconjunctivitis, Immunotherapy, Ragweed-SPIRE
Brief summary
The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose.
Interventions
None listed
Sponsors
Adiga Life Sciences, 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
° Previously randomised into and completed at least 6 of 8 treatment visits in Study TR006
Exclusion criteria
* Subject or Investigator have been informed of treatment received in Study TR006 * Subjects with significant allergy to animal dander * Any allergen immunotherapy since completing Study TR006 or use of prohibited therapies * History of recurrent acute sinusitis or chronic sinusitis * Received treatment with an investigational drug within 4 weeks of Screening * Unable to understand study requirements or unable to communicate clearly with Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Rhinoconjunctivitis Symptom Score | Approximately 12 months after first dose in TR006 |
Secondary
| Measure | Time frame |
|---|---|
| Rescue Medication Score | Approximately 12 months after first dose in TR006 |
| Patient Global Assessment | Approximately 12 months after first dose in TR006 |
| Skin Prick Test | Approximately 12 months after first dose in TR006 |
| Immunoglobulin E Test | Approximately 12 months after first dose in TR006 |
Countries
Canada
Outcome results
None listed