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

This study has been completed.
Sponsor:
Information provided by:
Circassia Limited
ClinicalTrials.gov Identifier:
NCT00729508
First received: August 4, 2008
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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).


Condition Intervention Phase
Cat Allergy
Biological: Cat-PAD
Phase 2

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
Official 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.

Resource links provided by NLM:


Further study details as provided by Circassia Limited:

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
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Cat-PAD
Cat-PAD dose 2X 4 administrations 2 weeks apart
Experimental: 2 Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 2 weeks apart
Experimental: 3 Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 4 weeks apart
Experimental: 4 Biological: Cat-PAD
Cat-PAD dose 1X 8 administrations 2 weeks apart
Placebo Comparator: 5 Biological: Cat-PAD
Placebo

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729508

Locations
Canada, Ontario
Cetero Research
Toronto, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Circassia Limited
Investigators
Principal Investigator: Deepen Patel, MD Allied Research International Inc-Cetero Research
  More Information

No publications provided

Responsible Party: Rod Hafner, Circassia Limited
ClinicalTrials.gov Identifier: NCT00729508     History of Changes
Other Study ID Numbers: CP002
Study First Received: August 4, 2008
Last Updated: July 7, 2009
Health Authority: Canada: Health Canada

Keywords provided by Circassia Limited:
Cat allergy
Immunotherapy
Cat-PAD
Environmental Exposure Chamber

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014