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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

⁃ The subject has provided written informed consent to participate in the study.

• Age 18-50 years.

• Moderate-to-severe allergic symptoms upon exposure to dogs.

• Dog allergy confirmed by positive specific IgE.

• Considered suitable by the investigator for treatment with Alutard SQ Dog in accordance with the approved Summary of Product Characteristics (SmPC).

• Female subjects of childbearing potential must use adequate contraception.

• A negative pregnancy test must be obtained prior to enrolment.

Locations
Other Locations
Sweden
Lund University Hospital
RECRUITING
Lund
Trelleborg Hospital
RECRUITING
Trelleborg
Contact Information
Primary
Carl Skröder, MD
carl.skroder@ki.com
+46 41055181
Backup
Lars Olaf Cardell, Professor
lars-olaf.cardell@ki.se
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 40
Treatments
Other: Treatment
All patients will receive the same treatment and serve as their own controls.
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov