Exposure Chamber Trial With Cat Immunotherapy

Cat Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987909
• Other study ID #: US-C-01
• Secondary ID: Cetero Research
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2009
• Last updated: August 17, 2010
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2010
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cat Allergy

Intervention

Biological:
• Specific allergen immunotherapy (placebo)
Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks
• Specific allergen immunotherapy
Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.
• Specific allergen immunotherapy
Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks
• Specific allergen immunotherapy
Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks

Locations

Country	Name	City	State
Canada	Cetero Research	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
ALK-Abelló A/S	Cetero Research, San Antonio

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		During 16 weeks of treatment	Yes
Secondary	Rhinoconjunctivitis symptom score		After 0, 8, and 16 weeks of treatment	No
Secondary	Overall rhinoconjunctivitis symptom score		After 0, 8, and 16 weeks of treatment	No
Secondary	Acoustic Rhinometry		After 0, 8, and 16 weeks of treatment	No
Secondary	Environmental Exposure Chamber Quality of Life		After 0, 8, and 16 weeks of treatment	No
Secondary	Serum immunology		After 0, 8, and 16 weeks of treatment	No
Secondary	Nasal secretion immunology		After 0 and 16 weeks of treatment	No
Secondary	Safety lab testing (clinical chemistry, haematology, urinalysis)		After 0 and 16 weeks of treatment	Yes