Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice

Condition(s) studied

Investigational drug(s) / intervention(s)

ALK Alutard SQ Dog: The study is based on Swedish guidelines with an up-titration period of 13 weeks from 100 SQ to 100.000 SQ. The maximum dose of 100.000 SQ is the given every 6-8 weeks for 3 years.

Study summary

STUDY DESIGN A single-center prospective before-and-after study evaluating the effect of Alutard SQ Dog in 40 men and women with moderate-to-severe dog allergy. Participants will serve as their own controls.

STUDY OUTLINE

The study will begin in the fall of 2026 and will be conducted over a one-year period. At baseline, participants will be asked to record their allergic symptoms, and assessments of lung function and nasal airflow will be performed. Blood samples will also be collected.

Following the baseline assessments, participants will undergo allergen provocation by entering a facility containing dogs. After a 30-minute exposure to dogs, participants will again be asked to record their allergic symptoms and will undergo the same assessments performed at baseline.

Allergen immunotherapy (AIT) with Alutard SQ Dog will then be initiated according to the standard treatment regimen and continued for one year. At the end of the treatment period, the same provocation procedure and assessments will be repeated. Participants will enter a facility containing dogs, followed by symptom recording and evaluation of lung function, nasal airflow, and relevant laboratory parameters.

Eligibility

Primary outcome measure(s)

• Total nasal symptom score (TNSS) — Patients will be exposed to dog allergen at baseline and again after one year of treatment with Alutard SQ dog. TNSS will be assessed at both occasions.
  Sneezing: 0-3 points Nasal itching: 0-3 points Nasal congestion: 0-3 points Rhinorrhea (runny nose): 0-3 points

Trial sites (2)

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