NCT04813380

Brief 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.
  • also to find if high sensitivity CRP can be an easy non-expensive test for diagnosis and follow up of allergic rhinitis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

March 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 27, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

March 20, 2021

Last Update Submit

December 18, 2022

Conditions

Effects of Immunotherapy

Keywords

Allergen immunotherapyMiRNA-223MiRNA-146a

Outcome Measures

Primary Outcomes (1)

  • MiRNA146a, microRNA 223 measurements

    Effect of sublingual immunotherapy on the miRNA146, MicroRNA 223 on allergic rhinitis patients

    6 months

Study Arms (2)

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

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

Other: Sublingual immunotherapy

Interventions

Sublingual immunotherapyOTHER

Sublingual immunotherapy give to allergic rhinitis patients for treatment

Oraltek Sublingual immunotherapy groupPlacebo

Eligibility Criteria

Age6 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient consent.
  • Patients between 6-60 years old suffering from allergic rhinitis clinically.
  • Positive skin prick test

You may not qualify if:

  • Chronic inflammatory condition as COPD, tuberculosis, aspergillosis and chronic hepatitis.
  • 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.
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Zohry Kamel Khater

Zagazig, 44511, Egypt

Location

Related Publications (14)

  • 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.

    PMID: 17765078BACKGROUND

  • 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.

    PMID: 30108335BACKGROUND

  • 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.

    PMID: 30509713BACKGROUND

  • 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.

    PMID: 25675113BACKGROUND

  • 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.

    PMID: 25195100BACKGROUND

  • 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.

    PMID: 26922928BACKGROUND

  • 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.

    PMID: 17182589BACKGROUND

  • 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.

    PMID: 26739406BACKGROUND

  • 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.

    PMID: 31406538BACKGROUND

  • 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.

    PMID: 23885321BACKGROUND

  • 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.

    PMID: 29906503BACKGROUND

  • 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.

    PMID: 26145982BACKGROUND

  • 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.

    PMID: 31139837BACKGROUND

  • 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.

    PMID: 31299142BACKGROUND

MeSH Terms

Interventions

Sublingual Immunotherapy

Intervention Hierarchy (Ancestors)

Desensitization, ImmunologicImmunosuppression TherapyImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 20, 2021

First Posted

March 24, 2021

Study Start

July 27, 2021

Primary Completion

September 10, 2022

Study Completion

October 10, 2022

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

EG(1)