Regulatory T-cells After Subcutaneous Immunotherapy

Completed

• Conditions: Specific Immunotherapy; Grass Pollen Allergy

• Registration Number: NCT01830673
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.

Trial Locations

Locations (1)

Johann Wolfgang Goethe-university; 🇩🇪 Frankfurt/M, Hessen, Germany