Cat-PAD Follow on Study

Circassia Limited170 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 approximately one year after the start of treatment.

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

170

Conditions

Cat Allergy Rhinoconjunctivitis

Interventions

PlaceboBIOLOGICAL

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

Cat-PAD Dose 1BIOLOGICAL

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

Cat-PAD Dose 2BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Cetero Research

Mississauga, Ontario, Canada

Outcomes

Primary Outcomes

Total Rhinoconjunctivitis Symptom Score

Time frame: 50-54 weeks after the start of treatment in CP005

Secondary Outcomes

Total Symptom scores for ocular and nasal symptoms

Time frame: 50-54 weeks after the start of treatment in CP005

Data from ClinicalTrials.gov

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