Exposure Chamber Trial With Cat Immunotherapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cat Allergy

Intervention / Treatment
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* Biological: Specific allergen immunotherapy (placebo)
* Biological: Specific allergen immunotherapy
* Biological: Specific allergen immunotherapy
* Biological: Specific allergen immunotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | During 16 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cat, Allergy, Immunotherapy, Sublingual, Exposure chamber, Safety, Rhinoconjunctivitis