ToleroMune Ragweed Follow up Study

Rhinoconjunctivitis Clinical Trial

Official title:

An Optional One Year Follow-up Study to Evaluate the Continued Efficacy of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448603
• Other study ID #: TR002B
• Status: Completed
• Phase: N/A
• First received: October 6, 2011
• Last updated: May 16, 2012
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ragweed Allergy
• Rhinoconjunctivitis

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Canada	Cetero Research	Mississauga	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Cetero Research, San Antonio

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Score		48-54 weeks after the start of treatment in TR002	No
Secondary	Total nasal and non-nasal symptom scores		48-54 weeks after the start of treatment in TR002	No
Secondary	Change in Immunoglobulin A (IgA)		50-56 weeks after the start of treatment in Tr002	No
Secondary	Change in Immunoglobulin E (IgE)		50-56 weeks after the start of treatment in Tr002	No
Secondary	Change in Immunoglobulin G4 (IgG4)		50-56 weeks after the start of treatment in Tr002	No
Secondary	Adverse Events		50-56 weeks after the start of treatment in TR002	Yes