Ragweed-SPIRE Follow-On Study

March 22, 2016 updated by: Circassia Limited

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kanata, Ontario, Canada, K2L 3C8
        • Kanata Allergy Services
      • Mississauga, Ontario, Canada
        • Inflamax Research
      • Windsor, Ontario, Canada, N8X 2G1
        • Windsor Allergy Asthma Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who completed at least 6 of 8 treatment visits in Study TR006

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TR006 Subjects
Subjects that have previously been randomised into study TR006

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Rhinoconjunctivitis Symptom Score
Time Frame: Approximately 12 months after first dose in TR006
Approximately 12 months after first dose in TR006

Secondary Outcome Measures

Outcome Measure
Time Frame
Rescue Medication Score
Time Frame: Approximately 12 months after first dose in TR006
Approximately 12 months after first dose in TR006
Patient Global Assessment
Time Frame: Approximately 12 months after first dose in TR006
Approximately 12 months after first dose in TR006
Skin Prick Test
Time Frame: Approximately 12 months after first dose in TR006
Approximately 12 months after first dose in TR006
Immunoglobulin E Test
Time Frame: Approximately 12 months after first dose in TR006
Approximately 12 months after first dose in TR006

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Circassia Limited

Collaborators

Adiga Life Sciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR006A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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