Ragweed-SPIRE Follow-On Study

Rhinoconjunctivitis Clinical Trial

Official title:

An Observational Follow-On Field Study to Evaluate the Continued Efficacy and Safety of Ragweed-SPIRE Treatment in Ragweed Allergic Subjects Approximately One Year After the Completion of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396680
• Other study ID #: TR006A
• Status: Completed
• Phase: N/A
• First received: March 19, 2015
• Last updated: March 22, 2016
• Start date: April 2015

Study information

• Verified date: March 2016
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conjunctivitis
• Ragweed Allergy
• Rhinoconjunctivitis

Locations

Country	Name	City	State
Canada	Kanata Allergy Services	Kanata	Ontario
Canada	Inflamax Research	Mississauga	Ontario
Canada	Windsor Allergy Asthma Associates	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Score		Approximately 12 months after first dose in TR006	No
Secondary	Rescue Medication Score		Approximately 12 months after first dose in TR006	No
Secondary	Patient Global Assessment		Approximately 12 months after first dose in TR006	No
Secondary	Skin Prick Test		Approximately 12 months after first dose in TR006	No
Secondary	Immunoglobulin E Test		Approximately 12 months after first dose in TR006	No