Phase III Cat-PAD Follow-on Study

Cat Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040844
• Other study ID #: CP007 A
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2018
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• previously completed clinical study CP007 [NCT01620762]

Exclusion Criteria:

• started allergen therapy since completing CP007

• Institutionalised due to a legal or regulatory order

Related Conditions & MeSH terms

• Cat Allergy

Intervention

Drug:
• Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]

• Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]

• Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Circassia Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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