Exposure Chamber Trial With Cat Immunotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects

NCT03414801

Allergic Rhinitis Rhinoconjunctivitis Exposure

COMPLETED NA

Mechanisms of Allergen Immunotherapy

NCT00001910

Asthma Hypersensitivity

COMPLETED

Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma

NCT06960382

Allergic Rhinitis Allergic Asthma

NOT_YET_RECRUITING PHASE1/PHASE2

Intralymphatic Immunotherapy for House Dust Mite, Dog, and Cat Allergy Using Tyrosine S® in Allergic Rhinitis

NCT02665754

Allergic Rhinitis

COMPLETED PHASE1

Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge

NCT03838731

Cat Allergy Mild Asthma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cat Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Solution resembling the active solutions, but without allergen extract

Group Type PLACEBO_COMPARATOR

Specific allergen immunotherapy (placebo)

Intervention Type BIOLOGICAL

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

Cat hair allergen extract, dose group 1

Group Type EXPERIMENTAL

Specific allergen immunotherapy

Intervention Type BIOLOGICAL

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

Cat hair allergen extract, dose group 2

Group Type EXPERIMENTAL

Specific allergen immunotherapy

Intervention Type BIOLOGICAL

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

Cat hair allergen extract, dose group 3

Group Type EXPERIMENTAL

Specific allergen immunotherapy

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Specific allergen immunotherapy (placebo)

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

Intervention Type BIOLOGICAL

Specific allergen immunotherapy

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

Intervention Type BIOLOGICAL

Specific allergen immunotherapy

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

Intervention Type BIOLOGICAL

Specific allergen immunotherapy

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No