Cat Allergy
Conditions
Keywords
Cat, Allergy, Immunotherapy, Sublingual, Exposure chamber, Safety, Rhinoconjunctivitis
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.
Interventions
BIOLOGICALSpecific allergen immunotherapy (placebo)
Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks
BIOLOGICALSpecific allergen immunotherapy
Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.
Sponsors
Cetero Research, San Antonio
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | During 16 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Rhinoconjunctivitis symptom score | 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 |
| Serum immunology | After 0, 8, and 16 weeks of treatment |
Countries
Canada
Outcome results
None listed