Status:
COMPLETED
Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects
Lead Sponsor:
Circassia Limited
Conditions:
Cat Allergy
Eligibility:
All Genders
18-65 years
Phase:
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 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 e...
Eligibility Criteria
Inclusion
- Minimum 1-year documented history of rhinoconjunctivitis (Nasal symptoms: sneezing, itching, rhinorrhoea, blockage; Ocular symptoms: itching, redness, soreness, watering) on exposure to cats. \[Subjects may also have controlled asthma (GINA classification 1)\].
- Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control.
- Subjects must achieve minimum qualifying symptom scores on at least one Symptom Diary Card during EEC exposure on the third and fourth day during the Baseline Challenge. Minimum qualifying symptom scores are defined as a TRSS of at least 10 out of a possible 24 and a TNSS of at least 6 out of a possible 12.
Exclusion
- Subjects with asthma falling under GINA 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 predicted.
- Subjects with an acute phase skin response to cat allergen with a mean wheal diameter \> 50mm.
- Subjects who suffer from seasonal allergic rhinoconjunctivitis, and cannot complete the clinical study outside the local pollen season or who have significant allergy to other animal dander that cannot be avoided during the study period.
- Subjects who cannot tolerate baseline challenge in the EEC.
- Allergen immunotherapy during the last 12 months or any history of Cat Dander immunotherapy.
- 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.
- History of immunopathological diseases.
- Positive test for Hepatitis B, Hepatitis C or HIV at screening.
- Have a history of severe drug allergy or anaphylactic reaction to food.
- A known allergy to thioglycerol.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00729508
Start Date
August 1 2008
End Date
May 1 2009
Last Update
July 8 2009
Active Locations (1)
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1
Cetero Research
Toronto, Ontario, Canada, L4W 1N2