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Exposure Chamber Trial With Cat Immunotherapy

Primary Purpose

Cat Allergy

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Specific allergen immunotherapy (placebo)

Specific allergen immunotherapy

About this trial

This is an interventional treatment trial for Cat Allergy focused on measuring Cat, Allergy, Immunotherapy, Sublingual, Exposure chamber, Safety, Rhinoconjunctivitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cetero Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Cat hair allergen extract, dose group 1

Cat hair allergen extract, dose group 2

Cat hair allergen extract, dose group 3

Arm Description

Solution resembling the active solutions, but without allergen extract

Outcomes

Primary Outcome Measures

Adverse Events

Secondary Outcome Measures

Rhinoconjunctivitis symptom score

Overall rhinoconjunctivitis symptom score

Acoustic Rhinometry

Environmental Exposure Chamber Quality of Life

Serum immunology

Nasal secretion immunology

Safety lab testing (clinical chemistry, haematology, urinalysis)

Full Information

NCT ID

NCT00987909

First Posted

September 28, 2009

Last Updated

August 17, 2010

Sponsor

ALK-Abelló A/S

Collaborators

Cetero Research, San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT00987909

Brief Title

Exposure Chamber Trial With Cat Immunotherapy

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

ALK-Abelló A/S

Collaborators

Cetero Research, San Antonio

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cat Allergy

Keywords

Cat, Allergy, Immunotherapy, Sublingual, Exposure chamber, Safety, Rhinoconjunctivitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Solution resembling the active solutions, but without allergen extract

Arm Title

Cat hair allergen extract, dose group 1

Arm Type

Experimental

Arm Title

Cat hair allergen extract, dose group 2

Arm Type

Experimental

Arm Title

Cat hair allergen extract, dose group 3

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Specific allergen immunotherapy (placebo)

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Specific allergen immunotherapy

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Specific allergen immunotherapy

Intervention Description

Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks

Intervention Type

Biological

Intervention Name(s)

Specific allergen immunotherapy

Intervention Description

Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks

Primary Outcome Measure Information:

Title

Adverse Events

Time Frame

During 16 weeks of treatment

Secondary Outcome Measure Information:

Title

Rhinoconjunctivitis symptom score

Time Frame