An Optional Two Year Follow Up Study to Study CP005A

Circassia Limited51 enrolled

Overview

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.

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

Conditions

Cat Allergy Rhinoconjunctivitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Cetero Research

Mississauga, Ontario, Canada

Outcomes

Primary Outcomes

Total Rhinoconjunctivitis Symptom Score

Time frame: 102-106 weeks after the start of treatment in CP005

Secondary Outcomes

Total Symptom scores for ocular and nasal symptoms

Time frame: 102-106 weeks after the start of treatment in CP005

Data from ClinicalTrials.gov

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