Intralymphatic cat-allergy immunotherapy for people with cat-induced rhinitis and asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 interventional study administers 3–4 intralymphatic injections of ALUTARD SQ Felis domesticus into an ultrasound-guided inguinal lymph node using much lower doses than standard subcutaneous immunotherapy. Participants are monitored for systemic allergic reactions following WAO guidelines, have serum tryptase measured, and undergo lung function tests and symptom questionnaires to evaluate asthma effects. Immunogenicity is measured by ImmunoCAP and basophil activation testing (CAST ELISA), and a modified nasal provocation test is used to gauge treatment effect. Results will be compared to conventional subcutaneous immunotherapy data to characterize safety, tolerability, and immune responses and to inform later efficacy trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Informed consent as documented by signature.
* Cat-dander-induced ARC as confirmed by patient history and type-1-sensitization to cat dander in skin and/or serum.

Exclusion Criteria:

* Hypersensitivity to phenol.
* Planned depot steroid injection for treatment of ARC
* Patients with uncontrolled asthma or FEV1 \< 70% of the predicted value in adults (after adequate pharmacological therapy).
* Patients with a severe asthma exacerbation in the past 3 months.
* Irreversible secondary changes in the affected organ (e.g., emphysema, bronchiectasis).
* Chronic obstructive or restrictive lung disease.
* Patients with active systemic autoimmune diseases and patients with immune deficiencies or immune weaknesses.
* Severe chronic inflammatory diseases.
* Concomitant infection with fever or other signs/symptoms of an acute or chronic infection at treatment visit.
* Chronic obstructive or restrictive lung disease
* Patients with malignant tumours that currently have clinical significance.
* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension, and treatment with beta-blockers).
* Known cardiovascular disease, i.e., not even NYHA class I.
* Use of ACE-blockers.
* Recent or on-going hepatic or renal disease.
* Severe chronic renal insufficiency (due to aluminium burden).
* Alcohol or drug abuse
* Women who are pregnant and breast feeding
* Women of childbearing age who wish to become pregnant or do not use contraception.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Participation in another study with investigational drug within the 30 days preceding and during the present study.

Where it's running

• University Hospital Zurich
  Zurich, Switzerland Recruiting

Study contacts

• Study coordinator: Pål Johansen, Professor, PhD
• Email: pal.johansen@usz.ch
• Phone: +41 44 255 8616

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.