Status:
COMPLETED
Safety of Cat-PAD in Cat Allergic Subjects
Lead Sponsor:
Circassia Limited
Conditions:
Cat Allergy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
This study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each cohort will undergo...
Eligibility Criteria
Inclusion
- A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1) on exposure to cats for at least 1 year.
- Late-Phase Allergic Skin Reaction (LPSR) to 0.010 HEP units Leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response on single arm.
Exclusion
- Subjects with asthma falling under GINA(2006) classification 2 (partly controlled) and 3 (uncontrolled).
- A history of anaphylaxis to cat allergen.
- Subjects with a cat specific IgE \>100 kU/L.
- Subjects with an FEV1 \<80% of normal.
- Subjects with an acute phase skin response to cat allergen with a weal diameter \> 30mm.
- Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season.
- Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever.
- Use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). If it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria.
- Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- Subjects being treated with beta-blockers
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00685711
Start Date
January 1 2008
End Date
July 1 2008
Last Update
August 6 2008
Active Locations (1)
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1
Allergy-Centre-Charité
Berlin, Germany, D-10117