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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


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
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