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Cat-PAD Exposure Chamber Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01033344
First Posted: December 16, 2009
Last Update Posted: October 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Adiga Life Sciences, Inc.
Cetero Research, San Antonio
Information provided by:
Circassia Limited
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

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 ]

Secondary Outcome Measures:
  • Symptom scores for ocular and nasal symptoms [ Time Frame: 0 and 18-22 weeks after start of treatment ]
  • Acoustic Rhinometry [ Time Frame: 0 and 18-22 weeks after start of treatment ]
  • Cat Specific IgE [ Time Frame: At 0 weeks and at follow up ]
  • Adverse Events [ Time Frame: During study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033344


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

Responsible Party: Dr Rod Hafner, Circassia Ltd
ClinicalTrials.gov Identifier: NCT01033344     History of Changes
Other Study ID Numbers: CP005
First Submitted: December 15, 2009
First Posted: December 16, 2009
Last Update Posted: October 1, 2010
Last Verified: September 2010

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