Cat-PAD Follow on Study

Circassia Pharmaceuticals

Status

Completed

Conditions

Cat Allergy

Rhinoconjunctivitis

Treatments

Biological: Placebo

Biological: Cat-PAD Dose 1

Biological: Cat-PAD Dose 2

Study type

Observational

Funder types

NETWORK

Industry

Identifiers

NCT01272323

CP005A

Details and patient eligibility

About

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.

Full 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.

Enrollment

170 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)