Regulatory T-cells After Subcutaneous Immunotherapy (RTCAS)

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Specific Immunotherapy; Grass Pollen Allergy

Study type: Observational

Funder types: Other

Identifiers

NCT01830673

FRA-2012-SCIT

Details and patient eligibility

About

The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical symptomes during the pollen season, Skin Prick test diamter >4mm or RAST class II or higher) were included. The patients were allocated to three study groups:

Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment) Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant grass pollen allergy without SCIT.

The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the patients to record symptoms during the adjacent pollen season. A blood sample was drawn to analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5, IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).

Enrollment: 68 patients

Sex: All

Ages: 7 to 28 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• informed consent,
• clinically relevant grass pollen allergy,
• age > 6 and < 28

Exclusion criteria

• severe unstable asthma,
• regular ingestion of antihistamine,
• systemic steroid therapy,
• lung funtcion VC < 70%,
• FEV1 < 65%

Trial design

68 participants in 3 patient groups

under SIT

Description:

patients completed second or third year of SIT. We include the patients directly after last SIT vaccination.

after SIT

Description:

Patients completed three years of SIT for at least three years. We included them as a follow up.

no SIT

Description:

These patients were determined randomly. They have a clinically relevant grass pollen allergy. They never had a SIT.