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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01272323
Enrollment
170
Registered
2011-01-07
Start date
2011-02-28
Completion date
2011-04-30
Last updated
2011-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cat Allergy, Rhinoconjunctivitis

Keywords

Cat allergy, Rhinoconjunctivitis

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.

Interventions

BIOLOGICALPlacebo

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

BIOLOGICALCat-PAD Dose 1

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

BIOLOGICALCat-PAD Dose 2

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Sponsors

Cetero Research, San Antonio
CollaboratorNETWORK
Adiga Life Sciences, Inc.
CollaboratorINDUSTRY
Circassia Limited
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Total Rhinoconjunctivitis Symptom Score50-54 weeks after the start of treatment in CP005

Secondary

MeasureTime frame
Total Symptom scores for ocular and nasal symptoms50-54 weeks after the start of treatment in CP005

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026