Clinical trial NCT01033344: Cat-PAD Exposure Chamber Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cat Allergy
Keywords: Cat allergy
Rhinoconjunctivitis
Exposure chamber
Immunotherapy
Cat-PAD
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
name: Cetero Research, San Antonio
First posted: 2009-12-16
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total Rhinoconjunctivitis Symptom Score
timeFrame: 0 and 18-22 weeks after start of treatment
Secondary outcomes:
measure: Symptom scores for ocular and nasal symptoms
timeFrame: 0 and 18-22 weeks after start of treatment
measure: Acoustic Rhinometry
timeFrame: 0 and 18-22 weeks after start of treatment
measure: Cat Specific IgE
timeFrame: At 0 weeks and at follow up
measure: Adverse Events
timeFrame: During study
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: Cetero Research, San Antonio
name: Deepen Patel, MD, CCF
role: PRINCIPAL_INVESTIGATOR
References: