Cat-PAD Exposure Chamber Study

This study has been completed.
Sponsor:
Collaborators:
Adiga Life Sciences
Cetero Research, San Antonio
Information provided by:
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01033344
First received: December 15, 2009
Last updated: September 30, 2010
Last verified: September 2010
  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 look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat allergic subjects following challenge to cat allergen in an EEC.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate Two Treatment Regimens 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:
  • Total Rhinoconjunctivitis Symptom Score [ Time Frame: 0 and 18-22 weeks after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom scores for ocular and nasal symptoms [ Time Frame: 0 and 18-22 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Acoustic Rhinometry [ Time Frame: 0 and 18-22 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Cat Specific IgE [ Time Frame: At 0 weeks and at follow up ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: During study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Solution resembling active solution but without peptides
Biological: Placebo
Intradermal injection 1x8 administrations 2 weeks apart
Experimental: Group 1
Cat-PAD dose group 1
Biological: Cat-PAD
Intradermal injection 1x8 administrations 2 weeks apart
Experimental: Group 2
Cat-PAD Dose group 2
Biological: Cat-PAD
Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo

Detailed Description:

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of Cat-PAD will be explored in subjects using an(Environmental Exposure Chamber)EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of three groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 18-65 years
  • Minimum 1-year history of rhinoconjunctivitis on exposure to cats. (Subjects may also have controlled asthma)
  • Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control
  • Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion Criteria:

  • "Partly controlled" and "uncontrolled" asthma
  • History of anaphylaxis to cat allergen
  • FEV1 of less than 70% of predicted
  • Subjects who cannot tolerate baseline challenge in the EEC
  • Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers or psychoactive drugs
  • A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033344

Locations
Canada, Ontario
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences
Cetero Research, San Antonio
Investigators
Principal Investigator: Deepen Patel, MD, CCF Cetero Research, San Antonio
  More Information

No publications provided

Responsible Party: Dr Rod Hafner, Circassia Ltd
ClinicalTrials.gov Identifier: NCT01033344     History of Changes
Other Study ID Numbers: CP005
Study First Received: December 15, 2009
Last Updated: September 30, 2010
Health Authority: Canada: Health Canada

Keywords provided by Circassia Limited:
Cat allergy
Rhinoconjunctivitis
Exposure chamber
Immunotherapy
Cat-PAD

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 22, 2014