Cat-PAD Follow on Study
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
1 other identifier
observational
170
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 20, 2011
May 1, 2011
2 months
January 6, 2011
May 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Rhinoconjunctivitis Symptom Score
50-54 weeks after the start of treatment in CP005
Secondary Outcomes (1)
Total Symptom scores for ocular and nasal symptoms
50-54 weeks after the start of treatment in CP005
Study Arms (3)
Placebo
Subjects previously randomised to receive placebo in study CP005
Cat-PAD Group 1
Subjects previously randomised to receive Cat-PAD dose 1 in study CP005
Cat-PAD Group 2
Subjects previously randomised to receive Cat-PAD dose 2 in study CP005
Interventions
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
Eligibility Criteria
Subject previously randomised in study CP005 and completed all dosing visits and the PTC
You may qualify if:
- Previously randomised in study CP005, completed all treatment visits and the Post Treatment Challenge (PTC).
You may not qualify if:
- "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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Circassia Limitedlead
- Cetero Research, San Antoniocollaborator
- Adiga Life Sciences, Inc.collaborator
Study Sites (1)
Cetero Research
Mississauga, Ontario, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Couroux, MD
Cetero Research, San Antonio
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 6, 2011
First Posted
January 7, 2011
Study Start
February 1, 2011
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
May 20, 2011
Record last verified: 2011-05