Status:
COMPLETED
Exposure Chamber Trial With Cat Immunotherapy
Lead Sponsor:
ALK-Abelló A/S
Collaborating Sponsors:
Cetero Research, San Antonio
Conditions:
Cat Allergy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00987909
Start Date
September 1 2009
End Date
May 1 2010
Last Update
August 18 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2