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Sponsored by: |
Circassia Limited |
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Information provided by: | Circassia Limited |
ClinicalTrials.gov Identifier: | NCT00867906 |
Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy.
This study will evaluate the safety and tolerability of multiple doses of Cat-PAD in controlled asthmatics treated with either inhaled salbutamol, inhaled corticosteroids or inhaled corticosteroids with a LABA and to explore the efficacy of Cat-PAD in these subjects using the Late Phase Skin Response, Early Phase Skin Response, and Conjunctival Provocation Test.
Condition | Intervention | Phase |
---|---|---|
Cat Allergy |
Biological: Cat-PAD Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomised, Placebo-Controlled Study to Assess the Safety of Cat-PAD in Cat Allergic Subjects With Controlled Asthma |
Estimated Enrollment: | 48 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort 1
Asthmatics using salbutamol only, subjects to receive either Cat-PAD or placebo comparator
|
Biological: Cat-PAD
Cat-PAD dose 1x8 administrations 2 weeks apart
Biological: Placebo
Placebo comparator, 1x8 administrations 2 weeks apart
|
Cohort 2
Asthmatics using inhaled corticosteroid, subjects to receive either Cat-PAD or placebo comparator
|
Biological: Cat-PAD
Cat-PAD dose 1x8 administrations 2 weeks apart
Biological: Placebo
Placebo comparator, 1x8 administrations 2 weeks apart
|
Cohort 3
Asthmatics using inhaled corticosteroid and LABA, subjects to receive either Cat-PAD or placebo comparator
|
Biological: Cat-PAD
Cat-PAD dose 1x8 administrations 2 weeks apart
Biological: Placebo
Placebo comparator, 1x8 administrations 2 weeks apart
|
This study is designed as a randomised, double-blind, placebo-controlled, parallel group, multiple dose study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis and controlled asthma. The efficacy of Cat-PAD will also be explored in these subjects using the EPSR, LPSR, CPT, and levels of cat specific IgE. A single centre will be initiated first, with a second centre included as a backup, if needed, to enable recruitment numbers to be met.
Three cohorts will be studied, depending on the treatment used to control the subject's asthma:Cohort 1 - inhaled salbutamol only, Cohort 2 - inhaled corticosteroid only, Cohort 3 - inhaled corticosteroid plus a LABA
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 8 weeks before randomisation and may consist of one or two visits to the clinic, at the investigator's discretion. Baseline Challenge will consist of a single visit 1 to 4 weeks before randomisation. In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to either 3 nmol Cat-PAD or placebo. Treatments will be administered every 2 weeks (±2 days) for 14 week
In Period 3, Post Treatment Challenge consist of a single visit 24-28 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Canada, Ontario | |
Alpha Medical Research | Recruiting |
Mississauga, Toronto, Ontario, Canada, L5A 3V4 | |
Contact: Inderjit Singh 1-905-566-1200 | |
Principal Investigator: Amarjit S Cheema, MD |
Principal Investigator: | Amarjit Cheema, MD | Alpha Medical Research |
Responsible Party: | Circassia Limited ( Dr Rod Hafner ) |
Study ID Numbers: | CP003 |
Study First Received: | March 19, 2009 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00867906 History of Changes |
Health Authority: | Canada: Health Canada |
Cat allergy Immunotherapy Cat-PAD |
Hypersensitivity Asthma |
Hypersensitivity Immune System Diseases |