Cat Allergy Clinical Trial
Official title:
A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety of Cat-PAD in Cat Allergic Subjects With Controlled Asthma
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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