Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients as Biomarkers for Efficacy of Sublingual Immunotherapy
NCT ID: NCT04813380
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2021-07-27
2022-10-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oraltek Sublingual immunotherapy group
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
Sublingual immunotherapy
Sublingual immunotherapy give to allergic rhinitis patients for treatment
Placebo
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
Sublingual immunotherapy
Sublingual immunotherapy give to allergic rhinitis patients for treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sublingual immunotherapy
Sublingual immunotherapy give to allergic rhinitis patients for treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients between 6-60 years old suffering from allergic rhinitis clinically.
3. Positive skin prick test
Exclusion Criteria
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
6 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zagazig University
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fatma Zohry Kamel Khater
Dr
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fatma Zohry Kamel Khater
Zagazig, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Gebert 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.
Hosseini 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.
Hou 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.
Jay DC, Nadeau KC. Immune mechanisms of sublingual immunotherapy. Curr Allergy Asthma Rep. 2014 Nov;14(11):473. doi: 10.1007/s11882-014-0473-1.
Jutel 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.
Levy 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.
Luo 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.
Moustafa 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.
Panganiban 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.
Panganiban 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.
Platts-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.
Specjalski 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.
Zhao 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Sublingual immunotherapy
Identifier Type: -
Identifier Source: org_study_id