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).
Primary Outcome Measures:
- Change from baseline in Total Rhinoconjunctivitis Symptom Score (TRSS) using all timepoints during PTC in Cat-PAD treatment groups compared to placebo. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in TRSS in Cat-PAD treatment groups at last two timepoints on third and fourth challenge days compared to placebo. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Change from baseline in individual symptom scores for ocular and nasal symptoms at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Change from baseline in TRSS at all timepoints during Exposure Chamber visit in pooled data from Cat-PAD treatment groups compared to placebo. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Proportion of subjects prematurely leaving the EEC due to intolerable symptoms during Post-Treatment Challenge (PTC) in Cat-PAD treatment groups compared to placebo. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Change from baseline in EEC-Rhinoconjunctivitis Quality of Life Questionnaire (EEC-RQOL) at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Exploratory analyses of change from baseline in asthma symptoms, FEV1 and use of rescue medication in Cat-PAD treatment groups compared to placebo in asthmatic subjects. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
120 |
| Study Start Date: |
August 2008 |
| Estimated Study Completion Date: |
April 2009 |
| Estimated Primary Completion Date: |
April 2009 (Final data collection date for primary outcome measure) |
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1: Experimental
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Biological: Cat-PAD
Cat-PAD dose 2X 4 administrations 2 weeks apart
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2: Experimental
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Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 2 weeks apart
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3: Experimental
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Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 4 weeks apart
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4: Experimental
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Biological: Cat-PAD
Cat-PAD dose 1X 8 administrations 2 weeks apart
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5: Placebo Comparator
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Biological: Cat-PAD
Placebo
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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.
Purpose
