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Cat-PAD Follow on Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272323
First Posted: January 7, 2011
Last Update Posted: May 20, 2011
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:
Cetero Research, San Antonio
Adiga Life Sciences, Inc.
Information provided by:
Circassia Limited
  Purpose

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 approximately one year after the start of treatment.


Condition Intervention
Cat Allergy Rhinoconjunctivitis Biological: Placebo Biological: Cat-PAD Dose 1 Biological: Cat-PAD Dose 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Optional 1 Year Follow up Study to Evaluate the Continued Efficacy 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: 50-54 weeks after the start of treatment in CP005 ]

Secondary Outcome Measures:
  • Total Symptom scores for ocular and nasal symptoms [ Time Frame: 50-54 weeks after the start of treatment in CP005 ]

Estimated Enrollment: 170
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Placebo
Subjects previously randomised to receive placebo in study CP005
Biological: Placebo
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
Cat-PAD Group 1
Subjects previously randomised to receive Cat-PAD dose 1 in study CP005
Biological: Cat-PAD Dose 1
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
Cat-PAD Group 2
Subjects previously randomised to receive Cat-PAD dose 2 in study CP005
Biological: Cat-PAD Dose 2
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Detailed Description:
Subjects who completed all dosing visits and the post treatment challenge (PTC) in study CP005 will be invited to attend the Screening Visit for CP005A. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject previously randomised in study CP005 and completed all dosing visits and the PTC
Criteria

Inclusion Criteria

  • Previously randomised in study CP005, completed all treatment visits and the Post Treatment Challenge (PTC).

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): NCT01272323


Locations
Canada, Ontario
Cetero Research
Mississauga, Ontario, Canada
Sponsors and Collaborators
Circassia Limited
Cetero Research, San Antonio
Adiga Life Sciences, Inc.
Investigators
Principal Investigator: Peter Couroux, MD Cetero Research, San Antonio
  More Information

Responsible Party: Dr Rod Hafner, VP R&D, Circassia Ltd
ClinicalTrials.gov Identifier: NCT01272323     History of Changes
Other Study ID Numbers: CP005A
First Submitted: January 6, 2011
First Posted: January 7, 2011
Last Update Posted: May 20, 2011
Last Verified: May 2011

Keywords provided by Circassia Limited:
Cat allergy
Rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases