An Optional Two Year Follow Up Study to Study CP005A

An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy 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

NCT01604018

Enrollment

Registered

2012-05-23

Start date

2012-02-29

Completion date

2012-04-30

Last updated

2012-05-24

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Total Rhinoconjunctivitis Symptom Score	102-106 weeks after the start of treatment in CP005

Secondary

Measure	Time frame
Total Symptom scores for ocular and nasal symptoms	102-106 weeks after the start of treatment in CP005

Countries

Canada

Outcome results