NCT05907733

Brief Summary

Allergic diseases such as asthma, allergic rhinitis (AR) and atopic dermatitis affect more than 25% of the world population and are the leading cause of illness in children. The complex interplay between genetic, environmental and immunological risk factors results in the manifestation of allergic diseases . The pathological presentation of allergic disease involves the activation of both the innate and adaptive immune systems, resulting in a multifaceted response in specific target tissues such as the airways . This response results in the recruitment of inflammatory cells to target tissues and the production of specific IgE antibodies, cytokines and other inflammatory mediators \[11\], \[12\]. It is well established that allergic inflammation triggers neuronal dysfunction, which activates specific inflammatory mechanisms, potentially leading to structural changes in the diseased tissue . Neurotrophins are a family of structurally related proteins initially discovered to be involved in regulating neuronal development and now known to govern both peripheral and central nerve growth. BDNF is a secretory protein belonging to the neurotrophin family and is involved in a range of neural processes during human development \[19\], \[20\]. In the early stages of development BDNF is essential for neurogenesis, survival and maturation of neuronal pathways. In the adult, alongside neurotransmitters, hormones and other neurotrophins, BDNF maintains synaptic plasticity, dendritic growth and the consolidation of long-term memory. The biological effect of BDNF is mediated via its binding to the trkB receptor. The activation of these receptors on eosinophils may be important in regulating the inflammatory cascade leading to allergic disease \[15\], \[24\]. Neurotrophin mediated activation of bronchial eosinophils might therefore play a role in the regulation of eosinophilic inflammation in allergic asthma . The BDNF gene is located on chromosome 11p13 and is alternatively spliced resulting in several different transcripts \[26\]. Genetic polymorphisms in BDNF have been associated with allergic phenotypes such atopic dermatitis \[27\] and asthma \[28\], \[29\], \[30\], \[31\] in different populations. The functional polymorphism rs6265 (Val66Met) has been shown to regulate intracellular trafficking and affect the secretion of BDNF \[32\]. Nerve growth factor (NGF), a neurotrophin that is expressed in the glandular, nasal epithelium, and peripheral nerves in the nasal mucosa, has been shown to induce biochemical and structural changes in nerves that can lead to hyper-responsiveness \[33\], \[34\], \[35\] The biological effects of neurotrophins are mediated by binding either to the high-affinity tyrosine kinase (trk) receptors or to the low-affinity receptors known as pan-neurotrophin receptor p-75.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

June 8, 2023

Last Update Submit

June 15, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • BDNF gene single nucleotide polymorphism with Allergic rhinitis risk

    will measure in blood

    2 months

  • Nerve growth factor serum level

    will measure in blood for the risk of Allergic rhinitis.

    2 months

  • IL-1 serum level

    will measure in blood for the risk of Allergic rhinitis.

    2 months

  • C-reactive protein serum level

    will measure in blood for the risk of Allergic rhinitis.

    2 months

Interventions

Genotyping.DIAGNOSTIC_TEST

5 ml biood withdrawen by venipuncture in EDTA tube DNA extraction will be done after centrifucation and used for quantatitive Real-time polymerase chain reaction.

Also known as: Measurement of Nerve growth factor serum level

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will be conducted on 50 patients 30 patients diagnosed as a clinical disease of AR according to the diagnostic criteria of AR based on, its Impact on Asthma criteria, the patient's history of allergic symptoms, and allergy test results using the ImmunoCAP system.

You may qualify if:

  • The chronic AR patients on anti-allergic .

You may not qualify if:

  • The chronic AR patients on anti-allergic therapy will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Nathan RA. The burden of allergic rhinitis. Allergy Asthma Proc. 2007 Jan-Feb;28(1):3-9. doi: 10.2500/aap.2007.28.2934.

    PMID: 17390749BACKGROUND
  • Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. doi: 10.1111/j.1398-9995.2007.01620.x. No abstract available.

    PMID: 18331513BACKGROUND
  • Devereux G. The increase in the prevalence of asthma and allergy: food for thought. Nat Rev Immunol. 2006 Nov;6(11):869-74. doi: 10.1038/nri1958.

    PMID: 17063187BACKGROUND
  • Vercelli D. Discovering susceptibility genes for asthma and allergy. Nat Rev Immunol. 2008 Mar;8(3):169-82. doi: 10.1038/nri2257.

    PMID: 18301422BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Genotype

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Central Study Contacts

zeinab M Kadry, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of medical biochemistry

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

June 1, 2023

Primary Completion

August 10, 2023

Study Completion

August 10, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations