Effect of Intralymphatic Immunotherapy at Basophil Response and Plasmacell Kinetic in Patients With Allergic Rhinitis.

NCT02255604 Phase 2 COMPLETED Results posted

The investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. The investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.

Details

Lead sponsor	University of Aarhus
Phase	Phase 2
Status	COMPLETED
Enrolment	36
Start date	2013-08
Completion	2017-02-01

Conditions

• Allergy
• Immune Tolerance
• Injection Site Discomfort

Interventions

• Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.
• alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.
• 0.1 ml Isoton saline

Primary outcomes

• Change in cSMS (Combined Symptom and Medication Score) — 3 years
  cSMS, Combined symptom and medication score, during grass pollen season in three years follow up. Minimal score 0, Maximal score 18. Higher score means worse outcome. Scale: Itchy/red eys: 0-3, Runny eyes: 0-3, Itchy nose: 0-3, Runny nose: 0-3, Block nose: 0-3, Sneezes: 0-3. Topical antihistamine 1.5 points/1 point. Nasal corticosteroid: 1 point/2 points. Oral antihistamine: 6 points/1 point. Oral prednisolon 1.5 point /3 points. Elements are summed to a combined score. Different combination methods exists. EAACI recommends means, i.e. symptoms 0-3 plus medicationscore 0-3. This scoringsystem was applied in the last follow-up year.

Countries

Denmark