Actively Recruiting
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
Led by University of Zurich · Updated on 2026-03-16
36
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and tolerability of intralymphatic immunotherapy (ILIT) with ALUTARD SQ Felis domesticus in patients with cat allergy-induced allergic rhinitis and asthma. The main questions it aims to answer are: Is ILIT with ALUTARD SQ Felis domesticus safe and well tolerated? What immunological responses play a role in ILIT? Researchers will compare the effects of ILIT to existing subcutaneous immunotherapy (SCIT) approaches to assess safety, tolerability, immunogenicity, and efficacy. Participants will: Receive 3-4 ILIT injections of ALUTARD SQ Felis domesticus into an inguinal lymph node, guided by ultrasound. Undergo safety monitoring, including WAO guidelines for systemic allergic reactions and tryptase measurement. Complete lung function tests, questionnaires, and a modified nasal provocation test to evaluate asthma effects and treatment efficacy. Provide blood samples for ImmunoCAP and basophil activation testing using CAST ELISA. Inclusion criteria: Adults aged 18-65 with cat-dander-induced allergic rhinitis and asthma. Exclusion criteria: Hypersensitivity to treatment components, systemic steroid use, uncontrolled asthma (FEV1 \< 70%), recent severe asthma exacerbations, or serious comorbidities. The study aims to generate data to inform future efficacy trials.
CONDITIONS
Official Title
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Adults aged 18 to 65 years.
- Confirmed cat-dander-induced allergic rhinitis and/or asthma based on patient history and allergy tests.
You will not qualify if you...
- Hypersensitivity to phenol or treatment components.
- Planned steroid injection for allergic rhinitis.
- Uncontrolled asthma or FEV1 less than 70% after treatment.
- Severe asthma attack within past 3 months.
- Irreversible lung damage such as emphysema or bronchiectasis.
- Chronic obstructive or restrictive lung disease.
- Active systemic autoimmune diseases or immune deficiencies.
- Severe chronic inflammatory diseases.
- Infection with fever or signs of acute or chronic infection at treatment visits.
- Malignant tumors with current clinical significance.
- Conditions complicating treatment of anaphylaxis (e.g., serious heart disease, severe hypertension, beta-blocker treatment).
- Known cardiovascular disease beyond NYHA class I.
- Use of ACE inhibitors.
- Recent or ongoing liver or kidney disease.
- Severe chronic kidney insufficiency.
- Alcohol or drug abuse.
- Pregnancy or breastfeeding.
- Women of childbearing age not using contraception or wishing to become pregnant.
- Inability to follow study procedures due to language, psychological, or cognitive issues.
- Participation in another investigational drug study within 30 days before and during this study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
P
Pål Johansen, Professor, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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