Clinical trial NCT00987909: Exposure Chamber Trial With Cat Immunotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cat Allergy
Keywords: Cat
Allergy
Immunotherapy
Sublingual
Exposure chamber
Safety
Rhinoconjunctivitis
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Cetero Research, San Antonio
First posted: 2009-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Adverse Events
timeFrame: During 16 weeks of treatment
Secondary outcomes:
measure: Rhinoconjunctivitis symptom score
timeFrame: After 0, 8, and 16 weeks of treatment
measure: Overall rhinoconjunctivitis symptom score
timeFrame: After 0, 8, and 16 weeks of treatment
measure: Acoustic Rhinometry
timeFrame: After 0, 8, and 16 weeks of treatment
measure: Environmental Exposure Chamber Quality of Life
timeFrame: After 0, 8, and 16 weeks of treatment
measure: Serum immunology
timeFrame: After 0, 8, and 16 weeks of treatment
measure: Nasal secretion immunology
timeFrame: After 0 and 16 weeks of treatment
measure: Safety lab testing (clinical chemistry, haematology, urinalysis)
timeFrame: After 0 and 16 weeks of treatment
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: Cetero Research, San Antonio
name: Deepen Patel, MD, CCFP
role: PRINCIPAL_INVESTIGATOR
References: