Cat-PAD Follow on Study

May 19, 2011 updated by: Circassia Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Subject previously randomised in study CP005 and completed all dosing visits and the PTC

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Rhinoconjunctivitis Symptom Score
Time Frame: 50-54 weeks after the start of treatment in CP005
50-54 weeks after the start of treatment in CP005

Secondary Outcome Measures

Outcome Measure
Time Frame
Total Symptom scores for ocular and nasal symptoms
Time Frame: 50-54 weeks after the start of treatment in CP005
50-54 weeks after the start of treatment in CP005

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Circassia Limited

Collaborators

Cetero Research, San Antonio
Adiga Life Sciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP005A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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