Ragweed-SPIRE Follow-On Study

NCT ID: NCT02396680

Last Updated: 2016-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Brief Summary

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

Detailed Description

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Conditions

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Rhinoconjunctivitis Ragweed Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TR006 Subjects

Subjects that have previously been randomised into study TR006

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adiga Life Sciences, Inc.

INDUSTRY

Sponsor Role collaborator

Circassia Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kanata Allergy Services

Kanata, Ontario, Canada

Site Status

Inflamax Research

Mississauga, Ontario, Canada

Site Status

Windsor Allergy Asthma Associates

Windsor, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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TR006A

Identifier Type: -

Identifier Source: org_study_id

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