Cat-PAD Follow on Study

Rhinoconjunctivitis Clinical Trial

Official title:

An Optional 1 Year Follow up Study to Evaluate the Continued Efficacy of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272323
• Other study ID #: CP005A
• Status: Completed
• Phase: N/A
• First received: January 6, 2011
• Last updated: May 19, 2011
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• 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 approximately one year after the start of treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

• Previously randomised in study CP005, completed all treatment visits and the Post Treatment Challenge (PTC).

Exclusion Criteria

• "Partly controlled" and "uncontrolled" asthma

• History of anaphylaxis to cat allergen

• FEV1 of less than 70% of predicted

• Subjects who cannot tolerate baseline challenge in the EEC

• Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers or psychoactive drugs

• A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cat Allergy
• Conjunctivitis
• Rhinoconjunctivitis

Intervention

Biological:
• Placebo
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
• Cat-PAD Dose 1
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
• Cat-PAD Dose 2
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Locations

Country	Name	City	State
Canada	Cetero Research	Mississauga	Ontario

Sponsors (3)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Score		50-54 weeks after the start of treatment in CP005	No
Secondary	Total Symptom scores for ocular and nasal symptoms		50-54 weeks after the start of treatment in CP005	No