Last updated on January 2014

A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects

---

Brief description of study

A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects

Detailed Study Description

A randomized, double-blind, superiority, multiple dose, placebo-controlled, parallel group, multi-centre, field study.

A minimum of 1182 subjects will be randomized into the study, 394 in each of 2 active treatment groups and placebo group, at a ratio of 1:1:1. Subjects will be stratified in each of the treatment groups according to asthma status and according to age, such that a target of 20%-30% of subjects are adolescent (12-17 years) and 70%-80% of subjects are adults (18-65 years). Subjects who withdraw may be replaced.

Subjects aged 12-65 years, with a documented history of moderate to severe allergic rhinoconjunctivitis only or allergic rhinoconjunctivitis plus GINA Step 1 controlled asthma on exposure to cats for at least 2 years.