Is Intralymphatic Allergen Immunotherapy effective and safe: A human randomized clinical trial - Intralympatic ASIT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016815-39-SE

Enrollment

100

Registered

2009-11-06

Start date

2010-01-15

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic rhinitis due to pollen from grass and betula verrucosa

Interventions

Trade Name: ALK-alutard SQ betulla Verrucosa Product Name: ALK-alutard SQ Betula verrucosa Pharmaceutical Form: Injection CAS Number: 8000045252 Other descriptive name: ALLERGENS, POLLEN & PLANT EXTRA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 18-65, - Seasonal allergic symptoms for grass verified by skin prick test, - Accepted informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnancy or nursing, - Autoimmune or collagen disease (known), - Cardiovascular disease, - Perennial pulmonary disease, - Hepatic disease, - Renal disease, - Cancer, - Any medication with a possible side-effect of interfering with the immune response, - Previous immuno- or chemotherapy, - Chronic diseases, - Upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease), - Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with ß-blockers), - Major metabolic disease, - Known or suspected allergy to the study product, - Alcohol or drug abuse, - Mental incapability of coping with the study, - Withdrawal of informed consent.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The Primary outcome measures is the effect on subjective symptoms following nasal allergen provocation two months after the end of the first season. An active il-ASIT group will be compared to a placebo il-ASIT group and a group that has been treated with traditional pharmaca during the season. ;Main Objective: Allergen immunotherapy is succesful in the treatment of hypersensitivity to a wide range of allergens. Allergen immunotherapy affects the long-term development of allergic rhinits and asthma. Currently the mode of allergen immunotherapy is very exhausting, time consuming and expensive for the patient and for health planners and implies regular patient visits for a period of 3-5 years. Emerging evidence shows that direct intralymphatic injection yields a faster beneficial result with a 1000-fold lower dose which will reduce both the dose necessary and the number of clinic visits associated with the treatment. The study objective is to evaluate if intralymphatic allergen specific immunotherapy (il-ASIT) can be an effective and safe way to alleviate seasonal symptoms of grass pollen induced allergic rhinitis. The Primary outcome measure is the effect on subjective symptoms following nasal allergen provocation two months after the end of the first season.;Secondary Objective: Secondary outcome measures are: - Safety parameter: registration of adverse events from the time of the first injection to 30 days after last injection. - Effects on quality of life measured during the first season using the SF-36 Health Survey (all three groups). - Evaluation of medicine - Skin prick reactions and inflammatory mediators in blood - Nasal provocations with grass pollen followed by blood sampling and nasal lavage will be performed out of season	—

Measure

Time frame

Primary end point(s): The Primary outcome measures is the effect on subjective symptoms following nasal allergen provocation two months after the end of the first season. An active il-ASIT group will be compared to a placebo il-ASIT group and a group that has been treated with traditional pharmaca during the season. ;Main Objective: Allergen immunotherapy is succesful in the treatment of hypersensitivity to a wide range of allergens. Allergen immunotherapy affects the long-term development of allergic rhinits and asthma. Currently the mode of allergen immunotherapy is very exhausting, time consuming and expensive for the patient and for health planners and implies regular patient visits for a period of 3-5 years. Emerging evidence shows that direct intralymphatic injection yields a faster beneficial result with a 1000-fold lower dose which will reduce both the dose necessary and the number of clinic visits associated with the treatment. The study objective is to evaluate if intralymphatic allergen specific immunotherapy (il-ASIT) can be an effective and safe way to alleviate seasonal symptoms of grass pollen induced allergic rhinitis. The Primary outcome measure is the effect on subjective symptoms following nasal allergen provocation two months after the end of the first season.;Secondary Objective: Secondary outcome measures are: - Safety parameter: registration of adverse events from the time of the first injection to 30 days after last injection. - Effects on quality of life measured during the first season using the SF-36 Health Survey (all three groups). - Evaluation of medicine - Skin prick reactions and inflammatory mediators in blood - Nasal provocations with grass pollen followed by blood sampling and nasal lavage will be performed out of season

—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 2, 2026