Regulatory T-cells After Subcutaneous Immunotherapy

Investigation of T-regulatory Cells After Subcutaneous Immunotherapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01830673

Acronym

RTCAS

Enrollment

Registered

2013-04-12

Start date

2011-10-31

Completion date

2012-10-31

Last updated

2014-07-25

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

Conditions

Grass Pollen Allergy, Specific Immunotherapy

Keywords

T-regulatory cells, TH1, TH2 cells, specific IgE, specific IgG, specific IgG4, IL2, IL5, IL10, IL12/23, Y-IFN, TNF-a

Brief summary

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 28 Years

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%

Design outcomes

Primary

Measure	Time frame	Description
Induction of regulatory t-cells	group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention	Determination of T-reulatory cells by FACS (staining for fox p3).

Secondary

Measure	Time frame	Description
TH1-cells by FACS	group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention	Staining for CD3, CD4, CD183
Th-2 cells by FACS	group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention	Staining for CD3, CD4, CD 194
Inflammatory cytokines	group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention	Cytokines (Il-2, Il-5, Il-10, Il-12/23, IFN-gamma, TNF-alpha) were determined by cytometric bead assay
Questionnaire	During the pollen season - for group 1: pollen season directly after completion of SCIT therapy, group 2: same pollen season as group 1, three years after completion of a 3 year SCIT, group 3: same pollen season as group 1 and 2	questionnaire to assess the quality of life (QoL), the clinical symptoms and medication scores during the SCIT adjacent pollen season.

Countries

Germany

Outcome results