ToleroMune Ragweed Follow up Study

NCT ID: NCT01448603

Last Updated: 2012-05-17

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

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-03-31

Brief Summary

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Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In the third National Health and Nutrition Examination Surveys54.3% of the population had positive test responses to one or more allergens, with the prevalence for short ragweed being 26.2%

The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing visits and the post treatment challenge (PTC) visit in study TR002 approximately one year after the start of treatment.

Detailed Description

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Subjects who were randomised in study TR002 and who completed all dosing visits and the PTC will be invited to attend the Screening Visit for TR002B. Subjects will attend the EEC for 4 visits on successive days. Following the final EEC visit a follow-up visit will be performed 3-10 days later.

Conditions

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Ragweed Allergy Rhinoconjunctivitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Placebo

Subjects previously randomised to placebo in TR002

Placebo

Intervention Type BIOLOGICAL

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

ToleroMune Ragweed Regimen 1

Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002

ToleroMune Ragweed

Intervention Type BIOLOGICAL

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

ToleroMune Ragweed Regimen 2

Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002

ToleroMune Ragweed

Intervention Type BIOLOGICAL

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

ToleroMune Ragweed regimen 3

Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002

ToleroMune Ragweed

Intervention Type BIOLOGICAL

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

ToleroMune Ragweed regimen 4

Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002

ToleroMune Ragweed

Intervention Type BIOLOGICAL

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

Interventions

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Placebo

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

Intervention Type BIOLOGICAL

ToleroMune Ragweed

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Previously randomised into study TR002 and completed all treatment visits and the PTC.

Exclusion Criteria

* History of asthma (a diagnosis of asthma in childhood may be allowed).
* Subjects with an FEV1 \<70% of predicted.
* Subjects being treated with beta-blockers.
* Developed a significant disease, disorder or inability to communicate, since completing study TR002 which, in the opinion of the Sponsor's medical representative, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.
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

Cetero Research, San Antonio

NETWORK

Sponsor Role collaborator

Circassia Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Couroux, MD

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

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Cetero Research

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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TR002B

Identifier Type: -

Identifier Source: org_study_id

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