Exposure Chamber Trial With Cat Immunotherapy

Phase 2

Completed

• Conditions: Cat Allergy
• Interventions: Biological: Specific allergen immunotherapy (placebo); Biological: Specific allergen immunotherapy

• Registration Number: NCT00987909
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-28
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-17
• Last Update Posted: 2010-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Specific allergen immunotherapy (placebo)	Solution resembling the active solutions, but without allergen extract
Cat hair allergen extract, dose group 1	Specific allergen immunotherapy	-
Cat hair allergen extract, dose group 2	Specific allergen immunotherapy	-
Cat hair allergen extract, dose group 3	Specific allergen immunotherapy	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	During 16 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cetero Research; 🇨🇦 Mississauga, Ontario, Canada