Exposure Chamber Trial With Cat Immunotherapy

This study has been completed.
Sponsor:
Collaborator:
Cetero Research, San Antonio
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00987909
First received: September 28, 2009
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Cat Allergy
Biological: Specific allergen immunotherapy (placebo)
Biological: Specific allergen immunotherapy
Phase 2

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

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: During 16 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rhinoconjunctivitis symptom score [ Time Frame: After 0, 8, and 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Overall rhinoconjunctivitis symptom score [ Time Frame: After 0, 8, and 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Acoustic Rhinometry [ Time Frame: After 0, 8, and 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Environmental Exposure Chamber Quality of Life [ Time Frame: After 0, 8, and 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Serum immunology [ Time Frame: After 0, 8, and 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Nasal secretion immunology [ Time Frame: After 0 and 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety lab testing (clinical chemistry, haematology, urinalysis) [ Time Frame: After 0 and 16 weeks of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Solution resembling the active solutions, but without allergen extract
Biological: Specific allergen immunotherapy (placebo)
Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks
Experimental: Cat hair allergen extract, dose group 1 Biological: Specific allergen immunotherapy
Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.
Experimental: Cat hair allergen extract, dose group 2 Biological: Specific allergen immunotherapy
Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks
Experimental: Cat hair allergen extract, dose group 3 Biological: Specific allergen immunotherapy
Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987909

Locations
Canada, Ontario
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
ALK-Abelló A/S
Cetero Research, San Antonio
Investigators
Principal Investigator: Deepen Patel, MD, CCFP Cetero Research, San Antonio
  More Information

No publications provided

Responsible Party: Senior Director Global Clinical Development, ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00987909     History of Changes
Other Study ID Numbers: US-C-01, Cetero Research - P2CR09001, Health Canada - 9427-A1556-24C
Study First Received: September 28, 2009
Last Updated: August 17, 2010
Health Authority: Canada: Health Canada

Keywords provided by ALK-Abelló A/S:
Cat
Allergy
Immunotherapy
Sublingual
Exposure chamber
Safety
Rhinoconjunctivitis

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014