Cat Allergy Clinical Trial
Official title:
An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD.
Verified date | August 2008 |
Source | Circassia Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Paul-Ehrlich-Institut |
Study type | Interventional |
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 safety of Cat-PAD administered as increasing single doses.
Status | Completed |
Enrollment | 88 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Allergy-Centre-Charité | Berlin |
Lead Sponsor | Collaborator |
---|---|
Circassia Limited |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of Cat-PAD | 0, 7, 21 days | Yes | |
Secondary | Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen. | Day 21 | No |
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