Investigation of T-regulatory Cells After Subcutaneous Immunotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Induction of regulatory t-cells
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 7 Years to 28 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%
Outcomes
Primary Outcomes
Induction of regulatory t-cells
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)
Investigators
Dr. med. Martin Rosewich
Principal Investigator
Johann Wolfgang Goethe University Hospital