Cat-PAD Follow on Study

This study has been completed.
Sponsor:
Collaborators:
Cetero Research, San Antonio
Adiga Life Sciences
Information provided by:
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01272323
First received: January 6, 2011
Last updated: May 19, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Symptom scores for ocular and nasal symptoms [ Time Frame: 50-54 weeks after the start of treatment in CP005 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: NCT01272323

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

No publications provided

Responsible Party: Dr Rod Hafner, VP R&D, Circassia Ltd
ClinicalTrials.gov Identifier: NCT01272323     History of Changes
Other Study ID Numbers: CP005A
Study First Received: January 6, 2011
Last Updated: May 19, 2011
Health Authority: Canada: Health Canada

Keywords provided by Circassia Limited:
Cat allergy
Rhinoconjunctivitis

Additional relevant MeSH terms:
Hypersensitivity
Conjunctivitis
Immune System Diseases
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 27, 2014