Cat-PAD Follow on Study

Completed

• Conditions: Cat Allergy; Rhinoconjunctivitis
• Interventions: Biological: Placebo; Biological: Cat-PAD Dose 1; Biological: Cat-PAD Dose 2

• Registration Number: NCT01272323
• Lead Sponsor: Circassia Limited

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Study Start: 2011-02
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-19
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects previously randomised to receive placebo in study CP005
Cat-PAD Group 1	Cat-PAD Dose 1	Subjects previously randomised to receive Cat-PAD dose 1 in study CP005
Cat-PAD Group 2	Cat-PAD Dose 2	Subjects previously randomised to receive Cat-PAD dose 2 in study CP005

Primary Outcome Measures

Name	Time	Method
Total Rhinoconjunctivitis Symptom Score	50-54 weeks after the start of treatment in CP005

Secondary Outcome Measures

Name	Time	Method
Total Symptom scores for ocular and nasal symptoms	50-54 weeks after the start of treatment in CP005

Trial Locations

Locations (1)

Cetero Research; 🇨🇦 Mississauga, Ontario, Canada