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Completed

NCT Number: NCT00987909

Exposure Chamber Trial With Cat Immunotherapy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific allergen immunotherapy (placebo)

Biological

Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks

Specific allergen immunotherapy

Biological

Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.

Primary outcomes

  1. Adverse Events

    Time frame: During 16 weeks of treatment

Secondary outcomes

  1. Rhinoconjunctivitis symptom score

    Time frame: After 0, 8, and 16 weeks of treatment

  2. Overall rhinoconjunctivitis symptom score

    Time frame: After 0, 8, and 16 weeks of treatment

  3. Acoustic Rhinometry

    Time frame: After 0, 8, and 16 weeks of treatment

  4. Environmental Exposure Chamber Quality of Life

    Time frame: After 0, 8, and 16 weeks of treatment

  5. Serum immunology

    Time frame: After 0, 8, and 16 weeks of treatment

  6. Nasal secretion immunology

    Time frame: After 0 and 16 weeks of treatment

  7. Safety lab testing (clinical chemistry, haematology, urinalysis)

    Time frame: After 0 and 16 weeks of treatment

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Collaborators

  • Cetero Research, San Antonio

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 1, 2009
Registry last updated
Aug 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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