Clinical trial NCT01448603: ToleroMune Ragweed Follow up Study
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ragweed Allergy
Rhinoconjunctivitis
Keywords: Ragweed allergy
ToleroMune ragweed
immunotherapy
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
name: Cetero Research, San Antonio
First posted: 2011-10-07
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously randomised in study TR002 and completed all dosing visits and the Post Treatment Challenge (PTC).

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Rhinoconjunctivitis Symptom Score
timeFrame: 48-54 weeks after the start of treatment in TR002
Secondary outcomes:
measure: Total nasal and non-nasal symptom scores
timeFrame: 48-54 weeks after the start of treatment in TR002
measure: Change in Immunoglobulin A (IgA)
timeFrame: 50-56 weeks after the start of treatment in Tr002
measure: Change in Immunoglobulin E (IgE)
timeFrame: 50-56 weeks after the start of treatment in Tr002
measure: Change in Immunoglobulin G4 (IgG4)
timeFrame: 50-56 weeks after the start of treatment in Tr002
measure: Adverse Events
timeFrame: 50-56 weeks after the start of treatment in TR002
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: Cetero Research, San Antonio
name: Peter Couroux, MD
role: PRINCIPAL_INVESTIGATOR
References: