An Optional Two Year Follow Up Study to Study CP005A

Completed

• Conditions: Cat Allergy; Rhinoconjunctivitis

• Registration Number: NCT01604018
• 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 and all visits in study CP005A approximately two years after the start of treatment.

Detailed Description

Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Last Update Submitted: 2012-05-23
• Last Update Posted: 2012-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Previously randomised into study CP005 and completed all visits in the follow-on study CP005A

Exclusion Criteria

• "Partly controlled" and "uncontrolled" asthma
• History of anaphylaxis to cat allergen
• Subjects with an FEV1 < 70% of predicted
• Subjects who cannot tolerate baseline challenge in the EEC
• Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs
• Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Rhinoconjunctivitis Symptom Score	102-106 weeks after the start of treatment in CP005

Secondary Outcome Measures

Name	Time	Method
Total Symptom scores for ocular and nasal symptoms	102-106 weeks after the start of treatment in CP005

Trial Locations

Locations (1)

Cetero Research; 🇨🇦 Mississauga, Ontario, Canada