Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects

July 7, 2009 updated by: Circassia Limited

A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate the 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. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will investigate the efficacy of 4 treatment regimens of Cat-PAD in cat allergic subjects following challenge to cat allergen in an environmental exposure chamber (EEC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is designed as a multicentre, randomised, double-blind, placebo-controlled study of 4 treatment regimens in up to 120 cat allergic subjects. A total of 24 subjects will be randomised into each treatment group. Each subject will undergo screening up to 4 weeks before treatment. Baseline challenge will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days a week before the first administration of Cat-PAD or placebo. Treatment will be administered as intradermal injections into the flexor surface of alternate forearms. There are 5 treatment regimens involving administration of Cat-PAD or placebo. Post-treatment challenge (PTC) will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days 18 weeks after the first administration of study medication.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
      • Toronto, Ontario, Canada, L4W 1N2
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum 1-year documented history of rhinoconjunctivitis (Nasal symptoms: sneezing, itching, rhinorrhoea, blockage; Ocular symptoms: itching, redness, soreness, watering) on exposure to cats. [Subjects may also have controlled asthma (GINA classification 1)].
  • Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control.
  • Subjects must achieve minimum qualifying symptom scores on at least one Symptom Diary Card during EEC exposure on the third and fourth day during the Baseline Challenge. Minimum qualifying symptom scores are defined as a TRSS of at least 10 out of a possible 24 and a TNSS of at least 6 out of a possible 12.

Exclusion Criteria:

  • Subjects with asthma falling under GINA classification 2 (partly controlled) and 3 (uncontrolled).
  • A history of anaphylaxis to cat allergen.
  • Subjects with a cat specific IgE >100 kU/L.
  • Subjects with an FEV1 <80% of predicted.
  • Subjects with an acute phase skin response to cat allergen with a mean wheal diameter > 50mm.
  • Subjects who suffer from seasonal allergic rhinoconjunctivitis, and cannot complete the clinical study outside the local pollen season or who have significant allergy to other animal dander that cannot be avoided during the study period.
  • Subjects who cannot tolerate baseline challenge in the EEC.
  • Allergen immunotherapy during the last 12 months or any history of Cat Dander immunotherapy.
  • Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
  • Subjects being treated with beta-blockers.
  • History of immunopathological diseases.
  • Positive test for Hepatitis B, Hepatitis C or HIV at screening.
  • Have a history of severe drug allergy or anaphylactic reaction to food.
  • A known allergy to thioglycerol.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Biological: Cat-PAD
Cat-PAD dose 2X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 4 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 8 administrations 2 weeks apart
Biological: Cat-PAD
Placebo
Experimental: 2
Biological: Cat-PAD
Cat-PAD dose 2X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 4 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 8 administrations 2 weeks apart
Biological: Cat-PAD
Placebo
Experimental: 3
Biological: Cat-PAD
Cat-PAD dose 2X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 4 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 8 administrations 2 weeks apart
Biological: Cat-PAD
Placebo
Experimental: 4
Biological: Cat-PAD
Cat-PAD dose 2X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 4 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 8 administrations 2 weeks apart
Biological: Cat-PAD
Placebo
Placebo Comparator: 5
Biological: Cat-PAD
Cat-PAD dose 2X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 2 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 4 administrations 4 weeks apart
Biological: Cat-PAD
Cat-PAD dose 1X 8 administrations 2 weeks apart
Biological: Cat-PAD
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in Total Rhinoconjunctivitis Symptom Score (TRSS) using all timepoints during PTC in Cat-PAD treatment groups compared to placebo.
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in TRSS in Cat-PAD treatment groups at last two timepoints on third and fourth challenge days compared to placebo.
Time Frame: 18 weeks
18 weeks
Change from baseline in individual symptom scores for ocular and nasal symptoms at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo.
Time Frame: 18 weeks
18 weeks
Change from baseline in TRSS at all timepoints during Exposure Chamber visit in pooled data from Cat-PAD treatment groups compared to placebo.
Time Frame: 18 weeks
18 weeks
Proportion of subjects prematurely leaving the EEC due to intolerable symptoms during Post-Treatment Challenge (PTC) in Cat-PAD treatment groups compared to placebo.
Time Frame: 18 weeks
18 weeks
Change from baseline in EEC-Rhinoconjunctivitis Quality of Life Questionnaire (EEC-RQOL) at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo.
Time Frame: 18 weeks
18 weeks
Exploratory analyses of change from baseline in asthma symptoms, FEV1 and use of rescue medication in Cat-PAD treatment groups compared to placebo in asthmatic subjects.
Time Frame: 18 weeks
18 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Circassia Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deepen Patel, MD, Allied Research International Inc-Cetero Research

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP002

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings