NCT01475188

Brief Summary

The purpose of this study is to determine whether specific subcutaneous immunotherapy affects fractions of regulatory T lymphocytes and histamine H2 receptor expression and ZAP70 in regulatory T lymphocytes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
Last Updated

November 21, 2011

Status Verified

November 1, 2011

Enrollment Period

3.6 years

First QC Date

November 16, 2011

Last Update Submit

November 18, 2011

Conditions

ImmunotherapySeasonal Allergic Rhinitis

Keywords

specific subcutaneous immunotherapyseasonal allergic rhinitisregulatory lymphocytessignal transductionhistamine receptor

Outcome Measures

Primary Outcomes (1)

  • numbers of regulatory T lymphocytes (nTregs)

    Numbers of regulatory T cells (nTregs) at baseline year both 6 weeks before the start of the pollen season, at the height of pollen season and 6 weeks after the termination of the pollen season and in the 2nd year of immunotherapy both 6 weeks before the start of the pollen season, at the height of pollen season and 6 weeks after the termination of the pollen.

    Change from the baseline year to the 2nd year of immunotherapy.

Secondary Outcomes (6)

  • Expression of zeta chain associated protein (ZAp70) in regulatory lymphocytes (nTregs)

    Change from the baseline year to the 2nd year of immunotherapy

  • Expression of histamine H2 receptor in regulatory lymphocytes (NTregs)

    Change from the baseline year to the second year of immunotherapy

  • Rhinoconjunctivitis symptom score

    Change from the baseline year to the second year of immunotherapy

  • Nasal eosinophilia

    Change from the basline year to the 2nd year of immunotherapy

  • Concentration of nitric oxide in exhaled air

    Change from the baseline year to the 2nd year of immunotherapy

  • +1 more secondary outcomes

Study Arms (2)

placebo

PLACEBO COMPARATOR

20 patients with intermittent allergic rhinitis sensitized to grass pollen allergens

Other: placebo

Specific subcutaneous immunotherapy

ACTIVE COMPARATOR

21 symptomatic patients with intermittent allergic rhinitis sensitized to grass pollen allergens

Drug: Allergovit

Interventions

AllergovitDRUG

commercially available grass pollen allergoid (100%), concentration A (1000 TU/ml, therapeutic units/ml)concentration B (10000 TU/ml).Patients were given subcutaneous injections with initial dose of 0.1 ml (concentration A) was increased once a 7 (+7) days until the highest tolerated dose (0.6, concentration B) was reached and SIT was continued with injections once every 4 - 6 weeks up to two years.

Also known as: Allergovit, grass pollen 100%, Allergopharma, Germany
Specific subcutaneous immunotherapy
placeboOTHER

placebo administered with the same scheme and doses as specific subcutaneous immunotherapy

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • seasonal allergic rhinitis with or without allergic conjunctivitis
  • sensitization to grass pollen allergens (confirmed with skin prick tests, conjunctival provocation test, specific IgE)
  • symptoms of allergic rhinitis with or without conjunctivitis for at least 2 years before the study

You may not qualify if:

  • sensitization to allergens, that could interfere with grass pollen
  • asthma
  • cystic fibrosis
  • ciliary dysmotility syndrome
  • bronchiectasis
  • smoking
  • tuberculosis
  • neoplastic disease
  • chronic sinusitis and nasal polyps
  • systemic glucocorticosteroids treatment
  • treatment with immunotherapy in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pneumonology and Allergy, Medical University of Lodz

Lodz, 90-153, Poland

Location

Related Publications (15)

  • Dieckmann D, Bruett CH, Ploettner H, Lutz MB, Schuler G. Human CD4(+)CD25(+) regulatory, contact-dependent T cells induce interleukin 10-producing, contact-independent type 1-like regulatory T cells [corrected]. J Exp Med. 2002 Jul 15;196(2):247-53. doi: 10.1084/jem.20020642.

    PMID: 12119349BACKGROUND

  • Baecher-Allan C, Viglietta V, Hafler DA. Human CD4+CD25+ regulatory T cells. Semin Immunol. 2004 Apr;16(2):89-98. doi: 10.1016/j.smim.2003.12.005.

    PMID: 15036232BACKGROUND

  • Fontenot JD, Gavin MA, Rudensky AY. Foxp3 programs the development and function of CD4+CD25+ regulatory T cells. Nat Immunol. 2003 Apr;4(4):330-6. doi: 10.1038/ni904. Epub 2003 Mar 3.

    PMID: 12612578BACKGROUND

  • Cao D, Malmstrom V, Baecher-Allan C, Hafler D, Klareskog L, Trollmo C. Isolation and functional characterization of regulatory CD25brightCD4+ T cells from the target organ of patients with rheumatoid arthritis. Eur J Immunol. 2003 Jan;33(1):215-23. doi: 10.1002/immu.200390024.

    PMID: 12594850BACKGROUND

  • Sakaguchi S. Naturally arising CD4+ regulatory t cells for immunologic self-tolerance and negative control of immune responses. Annu Rev Immunol. 2004;22:531-62. doi: 10.1146/annurev.immunol.21.120601.141122.

    PMID: 15032588BACKGROUND

  • Jordan MS, Riley MP, von Boehmer H, Caton AJ. Anergy and suppression regulate CD4(+) T cell responses to a self peptide. Eur J Immunol. 2000 Jan;30(1):136-44. doi: 10.1002/1521-4141(200001)30:13.0.CO;2-0.

    PMID: 10602035BACKGROUND

  • Apostolou I, Sarukhan A, Klein L, von Boehmer H. Origin of regulatory T cells with known specificity for antigen. Nat Immunol. 2002 Aug;3(8):756-63. doi: 10.1038/ni816. Epub 2002 Jul 1.

    PMID: 12089509BACKGROUND

  • Hori S, Nomura T, Sakaguchi S. Control of regulatory T cell development by the transcription factor Foxp3. Science. 2003 Feb 14;299(5609):1057-61. doi: 10.1126/science.1079490. Epub 2003 Jan 9.

    PMID: 12522256BACKGROUND

  • Shevach EM. CD4+ CD25+ suppressor T cells: more questions than answers. Nat Rev Immunol. 2002 Jun;2(6):389-400. doi: 10.1038/nri821.

    PMID: 12093005BACKGROUND

  • Thornton AM, Shevach EM. CD4+CD25+ immunoregulatory T cells suppress polyclonal T cell activation in vitro by inhibiting interleukin 2 production. J Exp Med. 1998 Jul 20;188(2):287-96. doi: 10.1084/jem.188.2.287.

    PMID: 9670041BACKGROUND

  • Fontenot JD, Rasmussen JP, Williams LM, Dooley JL, Farr AG, Rudensky AY. Regulatory T cell lineage specification by the forkhead transcription factor foxp3. Immunity. 2005 Mar;22(3):329-41. doi: 10.1016/j.immuni.2005.01.016.

    PMID: 15780990BACKGROUND

  • Jutel M, Akdis M, Blaser K, Akdis CA. Mechanisms of allergen specific immunotherapy--T-cell tolerance and more. Allergy. 2006 Jul;61(7):796-807. doi: 10.1111/j.1398-9995.2006.01175.x.

    PMID: 16792576BACKGROUND

  • Jutel M, Watanabe T, Klunker S, Akdis M, Thomet OA, Malolepszy J, Zak-Nejmark T, Koga R, Kobayashi T, Blaser K, Akdis CA. Histamine regulates T-cell and antibody responses by differential expression of H1 and H2 receptors. Nature. 2001 Sep 27;413(6854):420-5. doi: 10.1038/35096564.

    PMID: 11574888BACKGROUND

  • Liu H, Rhodes M, Wiest DL, Vignali DA. On the dynamics of TCR:CD3 complex cell surface expression and downmodulation. Immunity. 2000 Nov;13(5):665-75. doi: 10.1016/s1074-7613(00)00066-2.

    PMID: 11114379BACKGROUND

  • Ciebiada M, Kasztalska K, Gorska-Ciebiada M, Gorski P. ZAP70 expression in regulatory T cells in allergic rhinitis: effect of immunotherapy. Clin Exp Allergy. 2013 Jul;43(7):752-61. doi: 10.1111/cea.12124.

    PMID: 23786282DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

allergovit

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Paweł Górski, Prof, MD, PhD

    Department of Pneumonology and Allergy, Medical University of Lodz, Poland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof, MD, PhD

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 21, 2011

Study Start

March 1, 2007

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

November 21, 2011

Record last verified: 2011-11

Locations

PL(1)