Cat-PAD Follow on Study

NCT ID: NCT01272323

Last Updated: 2011-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cat Allergy Rhinoconjunctivitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Placebo

Subjects previously randomised to receive placebo in study CP005

Placebo

Intervention Type BIOLOGICAL

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

Cat-PAD Dose 1

Intervention Type BIOLOGICAL

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

Cat-PAD Dose 2

Intervention Type BIOLOGICAL

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Interventions

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Placebo

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Intervention Type BIOLOGICAL

Cat-PAD Dose 1

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Intervention Type BIOLOGICAL

Cat-PAD Dose 2

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cetero Research, San Antonio

NETWORK

Sponsor Role collaborator

Adiga Life Sciences, Inc.

INDUSTRY

Sponsor Role collaborator

Circassia Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Circassia Ltd

Principal Investigators

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Peter Couroux, MD

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

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Cetero Research

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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CP005A

Identifier Type: -

Identifier Source: org_study_id

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