Cat-PAD Exposure Chamber Study

A Double-blind, Randomized, Placebo-controlled Study to Evaluate Two Treatment Regimens of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01033344

Enrollment

210

Registered

2009-12-16

Start date

2010-01-31

Completion date

2010-09-30

Last updated

2010-10-01

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

Conditions

Cat Allergy

Keywords

Cat allergy, Rhinoconjunctivitis, Exposure chamber, Immunotherapy, Cat-PAD

Brief summary

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat allergic subjects following challenge to cat allergen in an EEC.

Detailed description

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of Cat-PAD will be explored in subjects using an(Environmental Exposure Chamber)EEC. The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation. In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of three groups and will receive treatment every 2 weeks (±2 days) for 14 weeks. In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

Interventions

BIOLOGICALPlacebo

Intradermal injection 1x8 administrations 2 weeks apart

BIOLOGICALCat-PAD

Intradermal injection 1x8 administrations 2 weeks apart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female, aged 18-65 years * Minimum 1-year history of rhinoconjunctivitis on exposure to cats. (Subjects may also have controlled asthma) * Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control * Minimum qualifying rhinoconjunctivitis symptom scores

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

Measure	Time frame
Total Rhinoconjunctivitis Symptom Score	0 and 18-22 weeks after start of treatment

Secondary

Measure	Time frame
Symptom scores for ocular and nasal symptoms	0 and 18-22 weeks after start of treatment
Acoustic Rhinometry	0 and 18-22 weeks after start of treatment
Cat Specific IgE	At 0 weeks and at follow up
Adverse Events	During study

Countries

Canada

Outcome results

None listed

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