NCT00987909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 18, 2010

Status Verified

August 1, 2010

Enrollment Period

6 months

First QC Date

September 28, 2009

Last Update Submit

August 17, 2010

Conditions

Cat Allergy

Keywords

CatAllergyImmunotherapySublingualExposure chamberSafetyRhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    During 16 weeks of treatment

Secondary Outcomes (7)

  • Rhinoconjunctivitis symptom score

    After 0, 8, and 16 weeks of treatment

  • Overall rhinoconjunctivitis symptom score

    After 0, 8, and 16 weeks of treatment

  • Acoustic Rhinometry

    After 0, 8, and 16 weeks of treatment

  • Environmental Exposure Chamber Quality of Life

    After 0, 8, and 16 weeks of treatment

  • Serum immunology

    After 0, 8, and 16 weeks of treatment

  • +2 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Solution resembling the active solutions, but without allergen extract

Biological: Specific allergen immunotherapy (placebo)

Cat hair allergen extract, dose group 1

EXPERIMENTAL
Biological: Specific allergen immunotherapy

Cat hair allergen extract, dose group 2

EXPERIMENTAL
Biological: Specific allergen immunotherapy

Cat hair allergen extract, dose group 3

EXPERIMENTAL
Biological: Specific allergen immunotherapy

Interventions

Specific allergen immunotherapy (placebo)BIOLOGICAL

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

Placebo
Specific allergen immunotherapyBIOLOGICAL

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

Cat hair allergen extract, dose group 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Deepen Patel, MD, CCFP

    Cetero Research, San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2009

First Posted

October 1, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

August 18, 2010

Record last verified: 2010-08

Locations

CA(1)