An Optional Two Year Follow Up Study to Study CP005A

Rhinoconjunctivitis Clinical Trial

Official title:

An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604018
• Other study ID #: CP005B
• Status: Completed
• Phase: N/A
• First received: May 21, 2012
• Last updated: May 23, 2012
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cat Allergy
• Conjunctivitis
• Rhinoconjunctivitis

Locations

Country	Name	City	State
Canada	Cetero Research	Mississauga	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Cetero Research, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Score		102-106 weeks after the start of treatment in CP005	No
Secondary	Total Symptom scores for ocular and nasal symptoms		102-106 weeks after the start of treatment in CP005	No