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Completed

NCT Number: NCT01830673

Regulatory T-cells After Subcutaneous Immunotherapy

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).

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Key information

Conditions

Grass Pollen Allergy Specific Immunotherapy

Age range

7 year–28 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johann Wolfgang Goethe-university

Frankfurt/M, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Primary outcomes

  1. 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

  1. TH1-cells by FACS

    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

    Staining for CD3, CD4, CD183

  2. Th-2 cells by FACS

    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

    Staining for CD3, CD4, CD 194

  3. Inflammatory cytokines

    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

    Cytokines (Il-2, Il-5, Il-10, Il-12/23, IFN-gamma, TNF-alpha) were determined by cytometric bead assay

  4. Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Investigation of T-regulatory Cells After Subcutaneous Immunotherapy

Acronym: RTCAS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2013
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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