An Optional Two Year Follow Up Study to Study CP005A

Circassia Pharmaceuticals

Status

Completed

Conditions

Cat Allergy

Rhinoconjunctivitis

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT01604018

CP005B

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 and all visits in study CP005A approximately two years after the start of treatment.

Full 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.

Enrollment

51 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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