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An Optional Two Year Follow Up Study to Study CP005A

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01604018
First Posted: May 23, 2012
Last Update Posted: May 24, 2012
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, Toronto
Information provided by (Responsible Party):
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 and all visits in study CP005A approximately two years after the start of treatment.


Condition
Cat Allergy Rhinoconjunctivitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy 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: 102-106 weeks after the start of treatment in CP005 ]

Secondary Outcome Measures:
  • Total Symptom scores for ocular and nasal symptoms [ Time Frame: 102-106 weeks after the start of treatment in CP005 ]

Enrollment: 51
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Placebo
Subjects previously randomized to receive placebo in study CP005 and completed CP005A.
Cat-PAD Group 1
Subjects previously randomized to receive Cat-PAD dose 1 in study CP005 and completed CP005A.
Cat-Pad Group 2
Subjects previously randomized to receive Cat-PAD dose 2 in study CP005 and completed CP005A.

Detailed Description:
Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.
  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
Sampling Method:   Non-Probability Sample
Study Population
Subjects previously randomised in study CP005 and completed all dosing and PTC in CP005 and all visits in CP005A.
Criteria

Inclusion Criteria:

- Previously randomised into study CP005 and completed all visits in the follow-on study CP005A

Exclusion Criteria:

  • "Partly controlled" and "uncontrolled" asthma
  • History of anaphylaxis to cat allergen
  • Subjects with an FEV1 < 70% of predicted
  • Subjects who cannot tolerate baseline challenge in the EEC
  • Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs
  • Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit
  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): NCT01604018


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

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01604018     History of Changes
Other Study ID Numbers: CP005B
First Submitted: May 21, 2012
First Posted: May 23, 2012
Last Update Posted: May 24, 2012
Last Verified: May 2012

Keywords provided by Circassia Limited:
Cat Allergy
Rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases