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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00729508
• Date of registration: 04/08/2008
• Primary sponsor: Circassia Limited
• Public title: Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects
• Scientific title: A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate the Efficacy of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber.
• Date of first enrolment: August 2008
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00729508
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Deepen Patel, MD
• Affiliation: Allied Research International Inc-Cetero Research

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cat Allergy

Intervention(s)

Biological: Cat-PAD

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

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]

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]

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]

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]

Secondary ID(s)

CP002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors