Phase III Cat-PAD Follow-on Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.

Official Title
-----------------
An Optional Prospective Follow-on Study to Evaluate the Continued Efficacy and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years After the Administration of Treatment

Conditions
-----------------
Cat Allergy

Intervention / Treatment
-----------------
* Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]
* Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]
* Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previously completed clinical study CP007 [NCT01620762] Exclusion Criteria: started allergen therapy since completing CP007 Institutionalised due to a legal or regulatory order
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cat-PAD Treatment 1<br>Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762].No further treatment received in CP007A | Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]<br> <br> |
| Other: Cat-PAD Treatment 2<br>Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762].No further treatment received in CP007A. | Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]<br> <br> |
| Other: Cat-PAD Treatment 3<br>Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]. No further treatment received in CP007A. | Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS]) | The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007). CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3. AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6. | 1 year after completing CP007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean TRSS | Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo. Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the first study (CP007). | 1 year after completion of CP007 | 
| Mean Component Scores of the TRSS (Nasal) | TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks 1 year after completing the original CP007 study. | 1 year after completion of CP007 | 
| Mean Component Scores of the TRSS (Ocular) | Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the original CP007 study | 1 year after completion of CP007 | 
| Mean Allergy Medication Score (AMS) | Mean AMS (Allergy medication score) in Cat-PAD treatment groups compared with placebo groups. The use of rhinoconjunctivitis rescue medications was recorded by the subject for a period of 21 days, on a daily basis just before bedtime, approximately 1 year after completing the original CP007 study. Rescue medication use was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive. | 1 year after completion of CP007 | 
| Mean RQLQ Score | The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects one year after the completion of the previous study (CP007). The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six. A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome. | 1 year after completion of CP007 |