Allergic RhinitisNCT05907733
Brain-derived Neurotrophic Factor (BDNF) Single Nucleotide Gene Polymorphism and Nerve Growth Factor as Risk Factors That Increase Severity of Allergic Rhinitis
An observational study of Allergic Rhinitis, run by Sohag University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Genotyping.
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 10 Aug 2023
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- The chronic AR patients on anti-allergic .
Who cannot join
- The chronic AR patients on anti-allergic therapy will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
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.
- Conditions
- Allergic Rhinitis
- Being tested
- Genotyping.
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotyping.Diagnostic test
Also called Measurement of Nerve growth factor serum level
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF gene single nucleotide polymorphism with Allergic rhinitis risk
will measure in blood
Measured: 2 months
Nerve growth factor serum level
will measure in blood for the risk of Allergic rhinitis.
Measured: 2 months
IL-1 serum level
will measure in blood for the risk of Allergic rhinitis.
Measured: 2 months
C-reactive protein serum level
will measure in blood for the risk of Allergic rhinitis.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jun 2023
- Primary completion10 Aug 2023 (estimated)
- Study completion10 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Mahmoud Kadry, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907733
- Sponsor's protocol ID
- Soh-Med-23-04-09PD
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nathan RA. The burden of allergic rhinitis. Allergy Asthma Proc. 2007 Jan-Feb;28(1):3-9. doi: 10.2500/aap.2007.28.2934.
PubMed 17390749Bousquet 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.
PubMed 18331513Devereux 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.
PubMed 17063187Vercelli D. Discovering susceptibility genes for asthma and allergy. Nat Rev Immunol. 2008 Mar;8(3):169-82. doi: 10.1038/nri2257.
PubMed 18301422
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-derived Neurotrophic Factor (BDNF) Single Nucleotide Gene Polymorphism and Nerve Growth Factor as Risk Factors That Increase Severity of Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05907733
- Acronym / sponsor ID
- Soh-Med-23-04-09PD
- Conditions
- Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 10 Aug 2023 (estimated)
- Study completion
- 10 Aug 2023 (estimated)
- First posted
- 18 Jun 2023 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- The chronic AR patients on anti-allergic .
Key exclusion criteria (1 listed)
- The chronic AR patients on anti-allergic therapy will be excluded.
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 |
|---|---|---|
| Genotyping.Also: Measurement of Nerve growth factor serum level5 ml biood withdrawen by venipuncture in EDTA tube DNA extraction will be done after centrifucation and used for quantatitive Real-time polymerase chain reaction. | Diagnostic test | – |
Primary outcome
BDNF gene single nucleotide polymorphism with Allergic rhinitis risk
Time frame: 2 months
will measure in blood
Nerve growth factor serum level
Time frame: 2 months
will measure in blood for the risk of Allergic rhinitis.
IL-1 serum level
Time frame: 2 months
will measure in blood for the risk of Allergic rhinitis.
C-reactive protein serum level
Time frame: 2 months
will measure in blood for the risk of Allergic rhinitis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 17390749Nathan RA. The burden of allergic rhinitis. Allergy Asthma Proc. 2007 Jan-Feb;28(1):3-9. doi: 10.2500/aap.2007.28.2934.
- Background: PubMed 18331513Bousquet 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.
- Background: PubMed 17063187Devereux 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.
- Background: PubMed 18301422Vercelli D. Discovering susceptibility genes for asthma and allergy. Nat Rev Immunol. 2008 Mar;8(3):169-82. doi: 10.1038/nri2257.
- Individual participant dataSharing planned: Undecided
Related trials for Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Sohag 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeinab M Kadry, lecturer (01225960747, zainbmahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF gene single nucleotide polymorphism with Allergic rhinitis risk (time frame: 2 months). The study lists 4 primary outcomes in all. 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 NCT05907733, which also lists 4 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 18 Jun 2023.