An Optional Two Year Follow Up Study to Study CP005A
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- Total Rhinoconjunctivitis Symptom Score [ Time Frame: 102-106 weeks after the start of treatment in CP005 ] [ Designated as safety issue: No ]
- Total Symptom scores for ocular and nasal symptoms [ Time Frame: 102-106 weeks after the start of treatment in CP005 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Subjects previously randomized to receive placebo in study CP005 and completed CP005A.
Cat-PAD Group 1
Subjects previously randomized to receive Cat-PAD dose 1 in study CP005 and completed CP005A.
Cat-Pad Group 2
Subjects previously randomized to receive Cat-PAD dose 2 in study CP005 and completed CP005A.
Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604018
|Mississauga, Ontario, Canada|
|Principal Investigator:||Peter Couroux, MD||Cetero Research, San Antonio|