ImmunotherapyPhase 4NCT01475188
Regulatory Lymphocytes in Patients Treated With Specific Immunotherapy
A Phase 4 study testing Allergovit in people with Immunotherapy and Seasonal Allergic Rhinitis, run by Ministry of Science and Higher Education, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immunotherapy, Seasonal Allergic Rhinitis
- What is being tested?
- Allergovit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2007to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- sensitization to allergens, that could interfere with grass pollen
- asthma
- cystic fibrosis
- ciliary dysmotility syndrome
- bronchiectasis
- smoking
Show all 11Show fewer
- tuberculosis
- neoplastic disease
- chronic sinusitis and nasal polyps
- systemic glucocorticosteroids treatment
- treatment with immunotherapy in the past
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pneumonology and Allergy, Medical University of Lodz
Lodz, 90-153
About this study
Official title: Regulatory Lymphocytes (Treg) in the Modulation of Allergic Inflammation in Patients Treated With Specific Immunotherapy.
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.
Read the detailed description
Allergy constitutes an important problem worldwide thus effective treatment is crucial for the reduction of symptoms severity, patients' activity and quality of life as well as for the reduction of direct and indirect costs of the disease. Specific allergen immunotherapy (SIT) is a potentially curative and specific method of treatment for allergic diseases, particularly for intermittent allergic rhinitis. Specific subcutaneous immunotherapy induce peripheral tolerance and suppress inflammation in tissue. In periphery, effector T cells unresponsiveness to antigens is mediated mainly by allergen specific regulatory T cells. Regulatory T cells induced peripherally comprise IL-10 producing type 1 regulatory T cells (Tr1) and regulatory T cells subset arising in vitro from CD4+CD25- and in vivo from peripheral memory T cells whereas naturally occurring Tregs (nTregs)originate in thymus and represent about 5% of the peripheral CD4 T cells and constitutively express high levels of the high-affinity IL-2 receptor (CD25hi). They coexpress Forkhead Box Protein P3 (Foxp3), glucocorticoid induced tumor necrosis factor receptor (GITR), cytotoxic T lymphocyte associated antigen (CTLA-4), and display low expression of alpha chain of the IL-7 receptor. Although clinical and immunological outcomes of SIT, that are associated with regulatory T cells functions were profoundly studied, little is known about the molecular mechanisms that are crucial for nTregs activation and function in the course of SIT. Since histamine is a key mediator in allergy that exerts its effect through 4 types of histamine receptors we decided to investigate the expression of histamine 2 receptor, that has potent immunomodulatory properties, in regulatory lymphocytes in patients treated with SIT. Furthermore, since T cell receptor activation is essential for T effector lymphocytes activation we wanted to check the expression of zeta chain associated protein (ZAP70), that constitutes a linker between TCR and lower levels of intracellular downstream signal transduction, in regulatory T cells in the course of SIT.
This is a 3-year prospective, placebo controlled, double blind trial of grass SIT. 41 patients with seasonal allergic rhinitis were randomized to receive SIT (n = 21) or placebo (n = 20) and 15 healthy were included as a control. The primary and secondary outcomes were assessed at baseline and during the treatment period - before the start of the pollen season, at the height of the pollen season and after the end of the pollen season.Results were compared between the treatment year and baseline and between the groups treated with SIT, placebo and healthy control.
- Conditions
- Immunotherapy, Seasonal Allergic Rhinitis
- Being tested
- Allergovit, placebo
- Keywords
- specific subcutaneous immunotherapy, seasonal allergic rhinitis, regulatory lymphocytes, signal transduction, histamine receptor
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllergovitDrug
Also called Allergovit, grass pollen 100%, Allergopharma, Germany
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.
placeboOther
placebo administered with the same scheme and doses as specific subcutaneous immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 20 patients with intermittent allergic rhinitis sensitized to grass pollen allergens Receives: Other: placebo |
| Specific subcutaneous immunotherapy | Active comparator | 21 symptomatic patients with intermittent allergic rhinitis sensitized to grass pollen allergens Receives: Drug: Allergovit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Expression of zeta chain associated protein (ZAP70) in 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.
Measured: Change from the baseline year to the 2nd year of immunotherapy
Expression of histamine H2 receptor in regulatory lymphocytes (NTregs)
Expression of histamine H2 receptor in 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.
Measured: Change from the baseline year to the second year of immunotherapy
Rhinoconjunctivitis symptom score
Change of the rhinoconjunctivitis symptoms score from the baseline year to the 2nd year of immunotherapy
Measured: Change from the baseline year to the second year of immunotherapy
Nasal eosinophilia
Numbers of eosinophils in nasal lavage during the 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.
Measured: Change from the basline year to the 2nd year of immunotherapy
Concentration of nitric oxide in exhaled air
Concentration of nitric oxide in exhaled air during the 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.
Measured: Change from the baseline year to the 2nd year of immunotherapy
Consumption of rescue medications
Comparison of the rescue medication intake during the baseline year and during the treatment
Measured: Change from the baseline year to the second year of imunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startMar 2007
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for ImmunotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Higher Education, Poland
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pawel Gorski, Ministry of Science and Higher Education, Poland
- Investigators
- Paweł Górski, Prof, MD, PhD, Study chair, Department of Pneumonology and Allergy, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475188
- Sponsor's protocol ID
- N 402 057 32/1788
- Other IDs
- 1788/PO1/2007/32
- Status last verified
- Nov 2011
- First submitted
- 16 Nov 2011
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12119349Baecher-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.
PubMed 15036232Fontenot 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.
PubMed 12612578Cao 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.
PubMed 12594850Sakaguchi 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.
PubMed 15032588Jordan 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.
PubMed 10602035Apostolou 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.
PubMed 12089509Hori 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.
PubMed 12522256Shevach EM. CD4+ CD25+ suppressor T cells: more questions than answers. Nat Rev Immunol. 2002 Jun;2(6):389-400. doi: 10.1038/nri821.
PubMed 12093005Thornton 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.
PubMed 9670041Fontenot 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.
PubMed 15780990Jutel 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.
PubMed 16792576Jutel 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.
PubMed 11574888Liu 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.
PubMed 11114379Ciebiada 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.
PubMed 23786282
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Lymphocytes (Treg) in the Modulation of Allergic Inflammation in Patients Treated With Specific Immunotherapy.
- ClinicalTrials.gov ID
- NCT01475188
- Acronym / sponsor ID
- N 402 057 32/1788
- Conditions
- Immunotherapy, Seasonal Allergic Rhinitis
- Keywords
- specific subcutaneous immunotherapy, seasonal allergic rhinitis, regulatory lymphocytes, signal transduction, histamine receptor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ministry of Science and Higher Education, PolandOther government
- Study start
- Mar 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Allergy constitutes an important problem worldwide thus effective treatment is crucial for the reduction of symptoms severity, patients' activity and quality of life as well as for the reduction of direct and indirect costs of the disease. Specific allergen immunotherapy (SIT) is a potentially curative and specific method of treatment for allergic diseases, particularly for intermittent allergic rhinitis. Specific subcutaneous immunotherapy induce peripheral tolerance and suppress inflammation in tissue. In periphery, effector T cells unresponsiveness to antigens is mediated mainly by allergen specific regulatory T cells. Regulatory T cells induced peripherally comprise IL-10 producing type 1 regulatory T cells (Tr1) and regulatory T cells subset arising in vitro from CD4+CD25- and in vivo from peripheral memory T cells whereas naturally occurring Tregs (nTregs)originate in thymus and represent about 5% of the peripheral CD4 T cells and constitutively express high levels of the high-affinity IL-2 receptor (CD25hi). They coexpress Forkhead Box Protein P3 (Foxp3), glucocorticoid induced tumor necrosis factor receptor (GITR), cytotoxic T lymphocyte associated antigen (CTLA-4), and display low expression of alpha chain of the IL-7 receptor. Although clinical and immunological outcomes of SIT, that are associated with regulatory T cells functions were profoundly studied, little is known about the molecular mechanisms that are crucial for nTregs activation and function in the course of SIT. Since histamine is a key mediator in allergy that exerts its effect through 4 types of histamine receptors we decided to investigate the expression of histamine 2 receptor, that has potent immunomodulatory properties, in regulatory lymphocytes in patients treated with SIT. Furthermore, since T cell receptor activation is essential for T effector lymphocytes activation we wanted to check the expression of zeta chain associated protein (ZAP70), that constitutes a linker between TCR and lower levels of intracellular downstream signal transduction, in regulatory T cells in the course of SIT.
This is a 3-year prospective, placebo controlled, double blind trial of grass SIT. 41 patients with seasonal allergic rhinitis were randomized to receive SIT (n = 21) or placebo (n = 20) and 15 healthy were included as a control. The primary and secondary outcomes were assessed at baseline and during the treatment period - before the start of the pollen season, at the height of the pollen season and after the end of the pollen season.Results were compared between the treatment year and baseline and between the groups treated with SIT, placebo and healthy control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placebo20 patients with intermittent allergic rhinitis sensitized to grass pollen allergens |
| Specific subcutaneous immunotherapy | Active comparator | Drug: Allergovit21 symptomatic patients with intermittent allergic rhinitis sensitized to grass pollen allergens |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- sensitization to allergens, that could interfere with grass pollen
- asthma
- cystic fibrosis
- ciliary dysmotility syndrome
- bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllergovitAlso: Allergovit, grass pollen 100%, Allergopharma, Germanycommercially 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. | Drug | Specific subcutaneous immunotherapy |
| placeboplacebo administered with the same scheme and doses as specific subcutaneous immunotherapy | Other | placebo |
Primary outcome
numbers of regulatory T lymphocytes (nTregs)
Time frame: Change from the baseline year to the 2nd year of immunotherapy.
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.
6 secondary outcomes
Expression of zeta chain associated protein (ZAp70) in regulatory lymphocytes (nTregs)
Time frame: Change from the baseline year to the 2nd year of immunotherapy
Expression of histamine H2 receptor in regulatory lymphocytes (NTregs)
Time frame: Change from the baseline year to the second year of immunotherapy
Rhinoconjunctivitis symptom score
Time frame: Change from the baseline year to the second year of immunotherapy
Nasal eosinophilia
Time frame: Change from the basline year to the 2nd year of immunotherapy
Concentration of nitric oxide in exhaled air
Time frame: Change from the baseline year to the 2nd year of immunotherapy
Consumption of rescue medications
Time frame: Change from the baseline year to the second year of imunotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2011.
- Background: PubMed 12119349Dieckmann 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.
- Background: PubMed 15036232Baecher-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.
- Background: PubMed 12612578Fontenot 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.
- Background: PubMed 12594850Cao 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.
- Background: PubMed 15032588Sakaguchi 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.
- Background: PubMed 10602035Jordan 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.
- Background: PubMed 12089509Apostolou 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.
- Background: PubMed 12522256Hori 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.
- Background: PubMed 12093005Shevach EM. CD4+ CD25+ suppressor T cells: more questions than answers. Nat Rev Immunol. 2002 Jun;2(6):389-400. doi: 10.1038/nri821.
- Background: PubMed 9670041Thornton 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.
- Background: PubMed 15780990Fontenot 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.
- Background: PubMed 16792576Jutel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Górski, Prof, MD, PhD study chair
Department of Pneumonology and Allergy, Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allergovit in people with Immunotherapy and Seasonal Allergic Rhinitis, run by Ministry of Science and Higher Education, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of regulatory T lymphocytes (nTregs) (time frame: Change from the baseline year to the 2nd year of immunotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01475188, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2011.