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Ragweed-SPIRE Follow-On Study

Completed
Conditions
Rhinoconjunctivitis
Ragweed Allergy
Registration Number
NCT02396680
Lead Sponsor
Circassia Limited
Brief Summary

The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
249
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total Rhinoconjunctivitis Symptom ScoreApproximately 12 months after first dose in TR006
Secondary Outcome Measures
NameTimeMethod
Rescue Medication ScoreApproximately 12 months after first dose in TR006
Skin Prick TestApproximately 12 months after first dose in TR006
Patient Global AssessmentApproximately 12 months after first dose in TR006
Immunoglobulin E TestApproximately 12 months after first dose in TR006

Trial Locations

Locations (3)

Kanata Allergy Services

🇨🇦

Kanata, Ontario, Canada

Inflamax Research

🇨🇦

Mississauga, Ontario, Canada

Windsor Allergy Asthma Associates

🇨🇦

Windsor, Ontario, Canada

Kanata Allergy Services
🇨🇦Kanata, Ontario, Canada

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