Exposure Chamber Trial With Cat Immunotherapy

ALK-Abelló

Status and phase: Completed; Phase 2

Conditions: Cat Allergy

Treatments: Biological: Specific allergen immunotherapy; Biological: Specific allergen immunotherapy (placebo)

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00987909

Health Canada - 9427-A1556-24C

US-C-01

Cetero Research - P2CR09001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Solution resembling the active solutions, but without allergen extract

Treatment:

Biological: Specific allergen immunotherapy (placebo)

Cat hair allergen extract, dose group 1

Experimental group

Treatment:

Biological: Specific allergen immunotherapy

Biological: Specific allergen immunotherapy

Biological: Specific allergen immunotherapy

Cat hair allergen extract, dose group 2

Experimental group

Treatment:

Biological: Specific allergen immunotherapy

Biological: Specific allergen immunotherapy

Biological: Specific allergen immunotherapy

Cat hair allergen extract, dose group 3

Experimental group

Treatment:

Biological: Specific allergen immunotherapy

Biological: Specific allergen immunotherapy

Biological: Specific allergen immunotherapy