Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects

Status Completed

Clinical Trial Summary

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 investigate the efficacy of 4 treatment regimens of Cat-PAD in cat allergic subjects following challenge to cat allergen in an environmental exposure chamber (EEC).

Clinical Trial Description

This study is designed as a multicentre, randomised, double-blind, placebo-controlled study of 4 treatment regimens in up to 120 cat allergic subjects. A total of 24 subjects will be randomised into each treatment group. Each subject will undergo screening up to 4 weeks before treatment. Baseline challenge will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days a week before the first administration of Cat-PAD or placebo. Treatment will be administered as intradermal injections into the flexor surface of alternate forearms. There are 5 treatment regimens involving administration of Cat-PAD or placebo. Post-treatment challenge (PTC) will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days 18 weeks after the first administration of study medication. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00729508
Study type	Interventional
Source	Circassia Limited
Contact
Status	Completed
Phase	Phase 2
Start date	August 2008
Completion date	May 2009

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See also
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