An Optional Two Year Follow Up Study to Study CP005A

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

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.

Study Overview

• Status: Completed
• Conditions: Cat Allergy; Rhinoconjunctivitis

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Rhinoconjunctivitis Symptom Score	102-106 weeks after the start of treatment in CP005

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Symptom scores for ocular and nasal symptoms	102-106 weeks after the start of treatment in CP005

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Adiga Life Sciences, Inc.; Cetero Research, Toronto

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (ESTIMATE): May 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 24, 2012
• Last Update Submitted That Met QC Criteria: May 23, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Rhinoconjunctivitis; Cat Allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: CP005B