Exposure Chamber Trial With Cat Immunotherapy

A Phase II Trial Assessing the Tolerability and Pharmacodynamic Effect of US SLIT Cat Hair in Subject With Cat Allergy and Investigating Efficacy Variables in an Environmental Exposure Chamber Model

The main purpose of this trial is to investigate if any of three different doses of cat hair immunotherapy is safe for treatment of cat allergic patients.

Study Overview

• Status: Completed
• Conditions: Cat Allergy
• Intervention / Treatment: Biological: Specific allergen immunotherapy (placebo); Biological: Specific allergen immunotherapy; Biological: Specific allergen immunotherapy; Biological: Specific allergen immunotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1N2
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A history of rhinoconjunctivitis on exposure to cats
• Positive Skin Prick Test response (wheal diameter at least 3 mm larger than the negative control
• Positive specific IgE against Fel d1 (at least IgE Class 2)
• Minimum qualifying rhinoconjunctivitis symptom score during EEC exposure at Visit 2

Exclusion Criteria:

• Uncontrolled asthma within the past 12 months, or asthma requiring regular use of inhaled corticosteroids
• FEV1 less than 80% of predicted
• Subjects who suffer from significant seasonal allergic rhinoconjunctivitis, and cannot complete the clinical trial outside the local pollen season, or who have significant allergy to other allergens (e.g. other animals or house dust mites) that cannot be avoided during the trial period
• Subjects who cannot tolerate baseline challenge in the Environmental Exposure Chamber
• History of anaphylaxis with cardio/respiratory symptoms
• A medical history of severe drug or food allergy with symptoms such as difficulty breathing, swelling of the face or a feeling of severe dizziness or increased heart rate
• Chronic urticaria
• History of severe cardiac disease
• Treatment with immunosuppressives, anti-IgE monoclonal antibodies, tricyclic antidepressants or MAOIs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Solution resembling the active solutions, but without allergen extract	Biological: Specific allergen immunotherapy (placebo); Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks
Experimental: Cat hair allergen extract, dose group 1	Biological: Specific allergen immunotherapy; Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.; Biological: Specific allergen immunotherapy; Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks; Biological: Specific allergen immunotherapy; Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks
Experimental: Cat hair allergen extract, dose group 2	Biological: Specific allergen immunotherapy; Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.; Biological: Specific allergen immunotherapy; Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks; Biological: Specific allergen immunotherapy; Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks
Experimental: Cat hair allergen extract, dose group 3	Biological: Specific allergen immunotherapy; Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.; Biological: Specific allergen immunotherapy; Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks; Biological: Specific allergen immunotherapy; Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	During 16 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Rhinoconjunctivitis symptom score	After 0, 8, and 16 weeks of treatment
Overall rhinoconjunctivitis symptom score	After 0, 8, and 16 weeks of treatment
Acoustic Rhinometry	After 0, 8, and 16 weeks of treatment
Environmental Exposure Chamber Quality of Life	After 0, 8, and 16 weeks of treatment
Serum immunology	After 0, 8, and 16 weeks of treatment
Nasal secretion immunology	After 0 and 16 weeks of treatment
Safety lab testing (clinical chemistry, haematology, urinalysis)	After 0 and 16 weeks of treatment

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Collaborators: Cetero Research, San Antonio
• Investigators: Principal Investigator: Deepen Patel, MD, CCFP, Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: September 28, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (Estimate): October 1, 2009

Study Record Updates

• Last Update Posted (Estimate): August 18, 2010
• Last Update Submitted That Met QC Criteria: August 17, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Safety; Allergy; Immunotherapy; Rhinoconjunctivitis; Cat; Sublingual; Exposure chamber
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Immunologic Factors
• Other Study ID Numbers: US-C-01; Cetero Research - P2CR09001; Health Canada - 9427-A1556-24C