Rhinoconjunctivitis Clinical Trial
Official title:
An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber
Verified date | May 2012 |
Source | Circassia Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Observational |
Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with
allergic rhinoconjunctivitis and/or asthma.
The purpose of this optional observational follow-on study is to further evaluate
rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who
completed all dosing visits in study CP005 and all visits in study CP005A approximately two
years after the start of treatment.
Status | Completed |
Enrollment | 51 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Previously randomised into study CP005 and completed all visits in the follow-on study CP005A Exclusion Criteria: - "Partly controlled" and "uncontrolled" asthma - History of anaphylaxis to cat allergen - Subjects with an FEV1 < 70% of predicted - Subjects who cannot tolerate baseline challenge in the EEC - Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs - Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Cetero Research | Mississauga | Ontario |
Lead Sponsor | Collaborator |
---|---|
Circassia Limited | Adiga Life Sciences, Inc., Cetero Research, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Rhinoconjunctivitis Symptom Score | 102-106 weeks after the start of treatment in CP005 | No | |
Secondary | Total Symptom scores for ocular and nasal symptoms | 102-106 weeks after the start of treatment in CP005 | No |
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