Cat-PAD Exposure Chamber Study

Cat Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033344
• Other study ID #: CP005
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2009
• Last updated: September 30, 2010
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cat Allergy

Intervention

Biological:
• Placebo
Intradermal injection 1x8 administrations 2 weeks apart
• Cat-PAD
Intradermal injection 1x8 administrations 2 weeks apart
• Cat-PAD
Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo

Locations

Country	Name	City	State
Canada	Cetero Research	Mississauga	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Cetero Research, San Antonio

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Score		0 and 18-22 weeks after start of treatment	No
Secondary	Symptom scores for ocular and nasal symptoms		0 and 18-22 weeks after start of treatment	No
Secondary	Acoustic Rhinometry		0 and 18-22 weeks after start of treatment	No
Secondary	Cat Specific IgE		At 0 weeks and at follow up	No
Secondary	Adverse Events		During study	Yes