Study Results
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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COMPLETED
109 participants
OBSERVATIONAL
2011-10-31
2012-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Placebo
Subjects previously randomised to placebo in TR002
Placebo
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
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
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
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
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.
ToleroMune Ragweed
No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Adiga Life Sciences, Inc.
INDUSTRY
Cetero Research, San Antonio
NETWORK
Circassia Limited
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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TR002B
Identifier Type: -
Identifier Source: org_study_id
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