An Optional Two Year Follow Up Study to Study CP005A

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

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

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 and all visits in study CP005A approximately two years after the start of treatment.

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Detailed Description

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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.

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 randomized to receive placebo in study CP005 and completed CP005A.

No interventions assigned to this group

Cat-PAD Group 1

Subjects previously randomized to receive Cat-PAD dose 1 in study CP005 and completed CP005A.

No interventions assigned to this group

Cat-Pad Group 2

Subjects previously randomized to receive Cat-PAD dose 2 in study CP005 and completed CP005A.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No