CompletedPhase 2/3

Is Intralymphatic Allergen Immunotherapy Effective and Safe?

Sweden15 participantsStarted 2014-04-25

Plain-language summary

15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-50, * Seasonal allergic symptoms for birch and/or grass verified by skin prick test, * Accepted informed consent 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 * Other 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 β-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

What they're measuring

Change in the serum-level of timothy specific IgG4 after 1 month

Timeframe: Change between baseline and 1 month after treatment.

Change in the serum-level of timothy specific IgG4 after 9 months

Timeframe: Change between baseline and 9 months after treatment.

Change in the serum-level of timothy specific IgG4 2 months after booster

Timeframe: Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).

Change in the serum-level of timothy specific IgG4 10 months after booster

Timeframe: Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).

Trial details

NCT IDNCT04210193

SponsorLars Olaf Cardell

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-01

View on ClinicalTrials.gov More Allergic Rhinitis Due to Grass Pollen trials