Effects of ImmunotherapyPhase 3NCT04813380
Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients as Biomarkers for Efficacy of Sublingual Immunotherapy
A Phase 3 study testing Sublingual immunotherapy in people with Effects of Immunotherapy, run by Zagazig University at 1 site in Egypt.
Trial summary
The aim of the study is: to evaluate the serum levels of miR-223 and miRNA146a and to assess their correlation with disease severity in allergic rhinitis patients and their role as biomarkers for efficacy of sublingual immunotherapy. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Effects of Immunotherapy
- What is being tested?
- Sublingual immunotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jul 2021to 10 Oct 2022
- Phase
- Phase 3
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient consent.
- Patients between 6-60 years old suffering from allergic rhinitis clinically.
- Positive skin prick test
Who cannot join
- 1- Chronic inflammatory condition as COPD, tuberculosis, aspergillosis and chronic hepatitis.
- 2- Other allergic diseases as bronchial asthma, allergic conjunctivitis and chronic urticaria 3- Those undergoing chronic treatment with systemic steroids or B- blockers 4- Systemic immunological disorders as systemic lupus erythematous, rheumatoid arthritis and systemic sclerosis.
- 5- Malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients: Correlation With Disease Severity and Their Role as Biomarkers for Efficacy of Sublingual Immunotherapy
The aim of the study is:
- to evaluate the serum levels of miR-223 and miRNA146a and to assess their correlation with disease severity in allergic rhinitis patients and their role as biomarkers for efficacy of sublingual immunotherapy.
- also to find if high sensitivity CRP can be an easy non-expensive test for diagnosis and follow up of allergic rhinitis patients.
Read the detailed description
Over the last decades the prevalence of allergic disease has steadily been rising and recent figures indicate that in the western world 10-25% of people are affected with allergic diseases ranging from food allergy, atopic dermatitis/ eczema, allergic rhinitis, hay fever to asthma.
Allergic rhinitis (AR) is the most frequent allergic disease in Western Europe that interferes with school attendance and performance, with a prevalence rate of 20-30%. Very few studies of the epidemiology were done about the prevalence of allergic rhinitis in Egypt as its prevalence was 9 %.
Allergic rhinitis is allergen-specific IgE-mediated inflammatory reactions which is characterized by excessive eosinophil infiltration, Th2 cytokine responses such as IL5, IL4, IL13, and mucus secretion. The prevalence of allergic rhinitis is increasing worldwide due to changes in the socioeconomic status, environmental factor, and occupational factor. AR burden on sleep and learning is substantial in children. Moreover, AR is considered a risk factor for subsequent asthma comorbidity.
Allergic rhinitis is characterized by nasal congestion, itching, rhinorrhea, and sneezing, which are manifested as a consequence of inappropriate immune responses mediated by allergen specific immunoglobulin E (IgE) antibodies toward otherwise harmless antigens such as pollen and house dust mite (HDM).
High-sensitivity-C-reactive protein (hs-CRP) is a well-known systemic inflammatory marker that is easy and inexpensive to measure, together with ESR, serum Ig-E and total eosinophil count are measured as laboratory markers of allergic diseases.
MicroRNAs (miRNAs) are small non-coding RNA molecules that are 18-22 nucleotides long and highly conserved throughout evolution. MiRNAs play important roles in numerous disease processes such as asthma and allergic rhinitis and that differential miRNA expression can identify novel subtypes of these diseases. As approximately 150 miRNAs are detectable in the blood, differential miRNA expression patterns may serve as a molecular fingerprint that aids in disease diagnosis, characterization, and prognosis.
MiRNAs may have particular clinical utility in allergic diseases. These diseases are characterized by tissue inflammation and are particularly difficult to diagnose and characterize considering that measuring releasing mediators, such as cytokines in blood which their characteristic measurement is unreliable . As a result, invasive methods (e.g., bronchoscopy and tissue biopsies) are needed to quantify inflammatory changes. It follows that miRNA expression profiling in blood and other body fluids becomes important for identifying and developing novel, non-invasive disease Biomarkers.
One of the most significantly upregulated molecules was miR-223 involved in eosinophilic inflammation and associated with lower regulatory T-cell numbers. It is well known that Treg cells play an important role in development of tolerance by producing IL-10. Thus, in the future inhibition of miR-223 could be considered an adjuvant treatment.
MiR-146a is one of the two members of the miR-146 miR family. It has been reported to be involved in a large number of cell activi¬ties, such as suppression of cancer growth, inhibition of inflam¬mation, regulation of the immune system and suppression of allergic inflammation. MiR-146a play a role in regulation of allergic diseases such as allergic rhinitis by modulating Treg cells.
Allergen-specific immunotherapy (AIT) is currently the only known causal effective treatment of IgE-mediated allergy. Sublingual immunotherapy is a well-established allergen-specific immunotherapy and a safe and effective strategy to reorient inappropriate immune responses in allergic patients.
MiR-146a may play a role in allergen immunotherapy of allergic diseases by modulating Treg cells. Also., high miR-223 expression is associated with lower regulatory T-cell numbers.
- Conditions
- Effects of Immunotherapy
- Being tested
- Sublingual immunotherapy
- Keywords
- Allergen immunotherapy, MiRNA-223, MiRNA-146a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual immunotherapyOther
Sublingual immunotherapy give to allergic rhinitis patients for treatment
| Study group | Role | What they receive |
|---|---|---|
| Oraltek Sublingual immunotherapy group | Active comparator | one drops under tongue for ten days then three Drops for another ten days then five drops for another ten days for three successive months then five drops every two days per week for two months then five drops one day per week for one months Receives: Other: Sublingual immunotherapy |
| Placebo | Placebo comparator | one drops under the tongue then three drops then five drops for three successive months then five drops every two days per week for two months then five drops one day per week for one months Receives: Other: Sublingual immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MiRNA146a, microRNA 223 measurements
Effect of sublingual immunotherapy on the miRNA146, MicroRNA 223 on allergic rhinitis patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start27 Jul 2021
- Primary completion10 Sep 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Effects of ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Zohry Kamel Khater, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813380
- Sponsor's protocol ID
- Sublingual immunotherapy
- Status last verified
- Dec 2022
- First submitted
- 20 Mar 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Allergen immunotherapy: a practice parameter second update. J Allergy Clin Immunol. 2007 Sep;120(3 Suppl):S25-85. doi: 10.1016/j.jaci.2007.06.019. No abstract available.
PubMed 17765078Gebert LFR, MacRae IJ. Regulation of microRNA function in animals. Nat Rev Mol Cell Biol. 2019 Jan;20(1):21-37. doi: 10.1038/s41580-018-0045-7.
PubMed 30108335Hosseini SA, Zilaee M, Shoushtari MH, Ghasemi Dehcheshmeh M. An evaluation of the effect of saffron supplementation on the antibody titer to heat-shock protein (HSP) 70, hsCRP and spirometry test in patients with mild and moderate persistent allergic asthma: A triple-blind, randomized placebo-controlled trial. Respir Med. 2018 Dec;145:28-34. doi: 10.1016/j.rmed.2018.10.016. Epub 2018 Oct 19.
PubMed 30509713Hou B, Murata M, Said AS, Sakaida H, Masuda S, Takahashi T, Zhang Z, Takeuchi K. Changes of micro-RNAs in asymptomatic subjects sensitized to Japanese cedar pollen after prophylactic sublingual immunotherapy. Allergy Rhinol (Providence). 2015 Jan;6(1):33-8. doi: 10.2500/ar.2015.6.0107. Epub 2015 Feb 11.
PubMed 25675113Jay DC, Nadeau KC. Immune mechanisms of sublingual immunotherapy. Curr Allergy Asthma Rep. 2014 Nov;14(11):473. doi: 10.1007/s11882-014-0473-1.
PubMed 25195100Jutel M, Kosowska A, Smolinska S. Allergen Immunotherapy: Past, Present, and Future. Allergy Asthma Immunol Res. 2016 May;8(3):191-7. doi: 10.4168/aair.2016.8.3.191.
PubMed 26922928Levy BD, Kohli P, Gotlinger K, Haworth O, Hong S, Kazani S, Israel E, Haley KJ, Serhan CN. Protectin D1 is generated in asthma and dampens airway inflammation and hyperresponsiveness. J Immunol. 2007 Jan 1;178(1):496-502. doi: 10.4049/jimmunol.178.1.496.
PubMed 17182589Luo X, Hong H, Tang J, Wu X, Lin Z, Ma R, Fan Y, Xu G, Liu D, Li H. Increased Expression of miR-146a in Children With Allergic Rhinitis After Allergen-Specific Immunotherapy. Allergy Asthma Immunol Res. 2016 Mar;8(2):132-40. doi: 10.4168/aair.2016.8.2.132. Epub 2015 Oct 22.
PubMed 26739406Moustafa Y, El Nady HG, Saber MM, Dabbous OA, Kamel TB, Abel-Wahhab KG, Sallam SF, Zaki DA. Assessment of Allergic Rhinitis among Children after Low-Level Laser Therapy. Open Access Maced J Med Sci. 2019 Jun 30;7(12):1968-1973. doi: 10.3889/oamjms.2019.477. eCollection 2019 Jun 30.
PubMed 31406538Panganiban RP, Pinkerton MH, Maru SY, Jefferson SJ, Roff AN, Ishmael FT. Differential microRNA epression in asthma and the role of miR-1248 in regulation of IL-5. Am J Clin Exp Immunol. 2012 Nov 15;1(2):154-65. Print 2012.
PubMed 23885321Panganiban RP, Lambert KA, Hsu MH, Laryea Z, Ishmael FT. Isolation and profiling of plasma microRNAs: Biomarkers for asthma and allergic rhinitis. Methods. 2019 Jan 1;152:48-54. doi: 10.1016/j.ymeth.2018.06.007. Epub 2018 Jun 12.
PubMed 29906503Platts-Mills TA. The allergy epidemics: 1870-2010. J Allergy Clin Immunol. 2015 Jul;136(1):3-13. doi: 10.1016/j.jaci.2015.03.048.
PubMed 26145982Specjalski K, Jassem E. MicroRNAs: Potential Biomarkers and Targets of Therapy in Allergic Diseases? Arch Immunol Ther Exp (Warsz). 2019 Aug;67(4):213-223. doi: 10.1007/s00005-019-00547-4. Epub 2019 May 28.
PubMed 31139837Zhao Y, Zhao Y, Zhang Y, Zhang L. HLA-II genes are associated with outcomes of specific immunotherapy for allergic rhinitis. Int Forum Allergy Rhinol. 2019 Nov;9(11):1311-1317. doi: 10.1002/alr.22384. Epub 2019 Jul 12.
PubMed 31299142
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients: Correlation With Disease Severity and Their Role as Biomarkers for Efficacy of Sublingual Immunotherapy
- ClinicalTrials.gov ID
- NCT04813380
- Acronym / sponsor ID
- Sublingual immunotherapy
- Conditions
- Effects of Immunotherapy
- Keywords
- Allergen immunotherapy, MiRNA-223, MiRNA-146a
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- 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 aim of the study is:
- to evaluate the serum levels of miR-223 and miRNA146a and to assess their correlation with disease severity in allergic rhinitis patients and their role as biomarkers for efficacy of sublingual immunotherapy.
- also to find if high sensitivity CRP can be an easy non-expensive test for diagnosis and follow up of allergic rhinitis patients.
Detailed description
Over the last decades the prevalence of allergic disease has steadily been rising and recent figures indicate that in the western world 10-25% of people are affected with allergic diseases ranging from food allergy, atopic dermatitis/ eczema, allergic rhinitis, hay fever to asthma.
Allergic rhinitis (AR) is the most frequent allergic disease in Western Europe that interferes with school attendance and performance, with a prevalence rate of 20-30%. Very few studies of the epidemiology were done about the prevalence of allergic rhinitis in Egypt as its prevalence was 9 %.
Allergic rhinitis is allergen-specific IgE-mediated inflammatory reactions which is characterized by excessive eosinophil infiltration, Th2 cytokine responses such as IL5, IL4, IL13, and mucus secretion. The prevalence of allergic rhinitis is increasing worldwide due to changes in the socioeconomic status, environmental factor, and occupational factor. AR burden on sleep and learning is substantial in children. Moreover, AR is considered a risk factor for subsequent asthma comorbidity.
Allergic rhinitis is characterized by nasal congestion, itching, rhinorrhea, and sneezing, which are manifested as a consequence of inappropriate immune responses mediated by allergen specific immunoglobulin E (IgE) antibodies toward otherwise harmless antigens such as pollen and house dust mite (HDM).
High-sensitivity-C-reactive protein (hs-CRP) is a well-known systemic inflammatory marker that is easy and inexpensive to measure, together with ESR, serum Ig-E and total eosinophil count are measured as laboratory markers of allergic diseases.
MicroRNAs (miRNAs) are small non-coding RNA molecules that are 18-22 nucleotides long and highly conserved throughout evolution. MiRNAs play important roles in numerous disease processes such as asthma and allergic rhinitis and that differential miRNA expression can identify novel subtypes of these diseases. As approximately 150 miRNAs are detectable in the blood, differential miRNA expression patterns may serve as a molecular fingerprint that aids in disease diagnosis, characterization, and prognosis.
MiRNAs may have particular clinical utility in allergic diseases. These diseases are characterized by tissue inflammation and are particularly difficult to diagnose and characterize considering that measuring releasing mediators, such as cytokines in blood which their characteristic measurement is unreliable . As a result, invasive methods (e.g., bronchoscopy and tissue biopsies) are needed to quantify inflammatory changes. It follows that miRNA expression profiling in blood and other body fluids becomes important for identifying and developing novel, non-invasive disease Biomarkers.
One of the most significantly upregulated molecules was miR-223 involved in eosinophilic inflammation and associated with lower regulatory T-cell numbers. It is well known that Treg cells play an important role in development of tolerance by producing IL-10. Thus, in the future inhibition of miR-223 could be considered an adjuvant treatment.
MiR-146a is one of the two members of the miR-146 miR family. It has been reported to be involved in a large number of cell activi¬ties, such as suppression of cancer growth, inhibition of inflam¬mation, regulation of the immune system and suppression of allergic inflammation. MiR-146a play a role in regulation of allergic diseases such as allergic rhinitis by modulating Treg cells.
Allergen-specific immunotherapy (AIT) is currently the only known causal effective treatment of IgE-mediated allergy. Sublingual immunotherapy is a well-established allergen-specific immunotherapy and a safe and effective strategy to reorient inappropriate immune responses in allergic patients.
MiR-146a may play a role in allergen immunotherapy of allergic diseases by modulating Treg cells. Also., high miR-223 expression is associated with lower regulatory T-cell numbers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oraltek Sublingual immunotherapy group | Active comparator | Other: Sublingual immunotherapyone drops under tongue for ten days then three Drops for another ten days then five drops for another ten days for three successive months then five drops every two days per week for two months then five drops one day per week for one months |
| Placebo | Placebo comparator | Other: Sublingual immunotherapyone drops under the tongue then three drops then five drops for three successive months then five drops every two days per week for two months then five drops one day per week for one months |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient consent.
- Patients between 6-60 years old suffering from allergic rhinitis clinically.
- Positive skin prick test
Key exclusion criteria (3 listed)
- 1- Chronic inflammatory condition as COPD, tuberculosis, aspergillosis and chronic hepatitis.
- 2- Other allergic diseases as bronchial asthma, allergic conjunctivitis and chronic urticaria 3- Those undergoing chronic treatment with systemic steroids or B- blockers 4- Systemic immunological disorders as systemic lupus erythematous, rheumatoid arthritis and systemic sclerosis.
- 5- Malignancy
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 |
|---|---|---|
| Sublingual immunotherapySublingual immunotherapy give to allergic rhinitis patients for treatment | Other | Oraltek Sublingual immunotherapy group, Placebo |
Primary outcome
MiRNA146a, microRNA 223 measurements
Time frame: 6 months
Effect of sublingual immunotherapy on the miRNA146, MicroRNA 223 on allergic rhinitis patients
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 20 Dec 2022.
- Background: PubMed 17765078Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Allergen immunotherapy: a practice parameter second update. J Allergy Clin Immunol. 2007 Sep;120(3 Suppl):S25-85. doi: 10.1016/j.jaci.2007.06.019. No abstract available.
- Background: PubMed 30108335Gebert LFR, MacRae IJ. Regulation of microRNA function in animals. Nat Rev Mol Cell Biol. 2019 Jan;20(1):21-37. doi: 10.1038/s41580-018-0045-7.
- Background: PubMed 30509713Hosseini SA, Zilaee M, Shoushtari MH, Ghasemi Dehcheshmeh M. An evaluation of the effect of saffron supplementation on the antibody titer to heat-shock protein (HSP) 70, hsCRP and spirometry test in patients with mild and moderate persistent allergic asthma: A triple-blind, randomized placebo-controlled trial. Respir Med. 2018 Dec;145:28-34. doi: 10.1016/j.rmed.2018.10.016. Epub 2018 Oct 19.
- Background: PubMed 25675113Hou B, Murata M, Said AS, Sakaida H, Masuda S, Takahashi T, Zhang Z, Takeuchi K. Changes of micro-RNAs in asymptomatic subjects sensitized to Japanese cedar pollen after prophylactic sublingual immunotherapy. Allergy Rhinol (Providence). 2015 Jan;6(1):33-8. doi: 10.2500/ar.2015.6.0107. Epub 2015 Feb 11.
- Background: PubMed 25195100Jay DC, Nadeau KC. Immune mechanisms of sublingual immunotherapy. Curr Allergy Asthma Rep. 2014 Nov;14(11):473. doi: 10.1007/s11882-014-0473-1.
- Background: PubMed 26922928Jutel M, Kosowska A, Smolinska S. Allergen Immunotherapy: Past, Present, and Future. Allergy Asthma Immunol Res. 2016 May;8(3):191-7. doi: 10.4168/aair.2016.8.3.191.
- Background: PubMed 17182589Levy BD, Kohli P, Gotlinger K, Haworth O, Hong S, Kazani S, Israel E, Haley KJ, Serhan CN. Protectin D1 is generated in asthma and dampens airway inflammation and hyperresponsiveness. J Immunol. 2007 Jan 1;178(1):496-502. doi: 10.4049/jimmunol.178.1.496.
- Background: PubMed 26739406Luo X, Hong H, Tang J, Wu X, Lin Z, Ma R, Fan Y, Xu G, Liu D, Li H. Increased Expression of miR-146a in Children With Allergic Rhinitis After Allergen-Specific Immunotherapy. Allergy Asthma Immunol Res. 2016 Mar;8(2):132-40. doi: 10.4168/aair.2016.8.2.132. Epub 2015 Oct 22.
- Background: PubMed 31406538Moustafa Y, El Nady HG, Saber MM, Dabbous OA, Kamel TB, Abel-Wahhab KG, Sallam SF, Zaki DA. Assessment of Allergic Rhinitis among Children after Low-Level Laser Therapy. Open Access Maced J Med Sci. 2019 Jun 30;7(12):1968-1973. doi: 10.3889/oamjms.2019.477. eCollection 2019 Jun 30.
- Background: PubMed 23885321Panganiban RP, Pinkerton MH, Maru SY, Jefferson SJ, Roff AN, Ishmael FT. Differential microRNA epression in asthma and the role of miR-1248 in regulation of IL-5. Am J Clin Exp Immunol. 2012 Nov 15;1(2):154-65. Print 2012.
- Background: PubMed 29906503Panganiban RP, Lambert KA, Hsu MH, Laryea Z, Ishmael FT. Isolation and profiling of plasma microRNAs: Biomarkers for asthma and allergic rhinitis. Methods. 2019 Jan 1;152:48-54. doi: 10.1016/j.ymeth.2018.06.007. Epub 2018 Jun 12.
- Background: PubMed 26145982Platts-Mills TA. The allergy epidemics: 1870-2010. J Allergy Clin Immunol. 2015 Jul;136(1):3-13. doi: 10.1016/j.jaci.2015.03.048.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sublingual immunotherapy in people with Effects of Immunotherapy, run by Zagazig University at 1 site in Egypt.
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 3 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 20 Dec 2022. 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
MiRNA146a, microRNA 223 measurements (time frame: 6 months). 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 NCT04813380, which also lists 14 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 20 Dec 2022.