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 range

18 Years – 55 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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