Cat-PAD Follow on Study

Study Overview
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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.

Official Title
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An Optional 1 Year Follow up Study to Evaluate the Continued Efficacy of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber

Conditions
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Cat Allergy, Rhinoconjunctivitis

Intervention / Treatment
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* Biological: Placebo
* Biological: Cat-PAD Dose 1
* Biological: Cat-PAD Dose 2


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo<br>Subjects previously randomised to receive placebo in study CP005 | Biological: Placebo<br>* No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.<br>|
| Cat-PAD Group 1<br>Subjects previously randomised to receive Cat-PAD dose 1 in study CP005 | Biological: Cat-PAD Dose 1<br>* No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.<br>|
| Cat-PAD Group 2<br>Subjects previously randomised to receive Cat-PAD dose 2 in study CP005 | Biological: Cat-PAD Dose 2<br>* No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Rhinoconjunctivitis Symptom Score |  | 50-54 weeks after the start of treatment in CP005 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Symptom scores for ocular and nasal symptoms |  | 50-54 weeks after the start of treatment in CP005 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhinoconjunctivitis, Cat allergy