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Allergic RhinitisNCT06709092

Study on the Effect and Mechanism of Lupatadine Fumarate in the Treatment of Allergic Rhinitis

A study testing lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals) in people with Allergic Rhinitis, run by Cheng Lei at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In China, the prevalence of allergic rhinitis reaches 17.6% and is increasing year by year, seriously affecting the quality of life of patients. Some patients still cannot be effectively treated. So it is urgent to study the pathogenesis of AR and find new therapeutic targets. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Allergic Rhinitis
What is being tested?
lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesChina
Study dates
1 Mar 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult patients (18-65 years).
  • Patients with allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).

Who cannot join

  • Received glucocorticoids, immunomodulatory, antihistamine drugs, and other medications that may affect the study results within the last 1 month.
  • Nasal diseases such as upper respiratory tract infections, chronic sinusitis with or without nasal polyps, and nasal sinus tumors.
  • History of nasal sinus surgery.
  • With other immune and allergic diseases.
  • Patients with a combination of severe cardiac, cerebrovascular or pulmonary - diseases, aspirin triad, primary ciliary dyskinesia, immune deficiency, and coagulation disorders.
  • Pregnant women.
  • Smokers.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210000

    Lei Cheng, Doctor, 0086-13776620807, chenglei@jsph.org.cn

    Not yet recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210000

    Cheng Lei, Chief physician, 0086-13776620807, chenglei@jsph.org.cn

    Recruiting

Other trials in China

About this study

In China, the prevalence of allergic rhinitis reaches 17.6% and is increasing year by year, seriously affecting the quality of life of patients. Some patients still cannot be effectively treated. So it is urgent to study the pathogenesis of AR and find new therapeutic targets. Lupatadine fumarate has the dual effects of antihistamine and platelet-activating factor (PAF), and it is the only potent and highly effective allergy drug with both antihistamine and PAF antagonism currently on the marke. The exact mechanism of Lupatadine fumarate in relieving nasal congestion in patients with AR is unknown. Tight junction proteins (TJs) play an important role in maintaining endothelial barrier function, and TJ disruption disrupts barrier function and promotes inflammation. 15-LOX(15-lipoxygenase) disrupts tight junctions at the blood-brain barrier. It increases cerebral vascular permeability and contributes to cerebral edema. In a mouse model of atherosclerosis, 15(S)-HETE, the major metabolite of 15-LOX, enhances the phosphorylation of ZO-2 at the Thr-1/1 residue through MEK1-ERK770/772 activation, leading to the dissociation of ZO-1 from occludin and disrupting the endothelial TJ and its barrier function. So we want to study the effects and mechanisms of lupatadine fumarate in the treatment of allergic rhinitis (AR) and whether lupatadine fumarate is directly related to 15-LO1.

Being tested
lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals)
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals)Drug

    For patients with AR, patients were given lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals) 1 tablet once daily at bedtime for 14 days.

Study groups in NCT06709092
Study groupRoleWhat they receive
Allergic rhinitisExperimentalFor patients with AR, patients were given lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals) 1 tablet once daily at bedtime for 14 days.
Receives: Drug: lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rhinoconjunctivitis Quality of Life Questionnaire

    To measure the functional impairments that are most troublesome to adult patients as a result of their rhinoconjunctivitis. Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. 7-point scale (0 = not impaired at all - 6 = severely impaired). Higher scores reflect lower quality of life.

    Measured: baseline and 14 days

  2. Visual analogue scale

    Results VAS are well validated for the measurement of AR symptoms and correlate well with the ARIA (allergic rhinitis and its impact on asthma) severity classification. Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. Range: 0-10. Higher scores reflect more pain and severity.

    Measured: baseline and 14 days

  3. The concentration of interleukin 4(IL-4), interleukin 5(IL-5), interleukin 13(IL-13)

    It reflects Th2 immune response in patients with allergic rhinitis

    Measured: baseline and 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start1 Mar 2024
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06709092
Sponsor's protocol ID
2023-SR-674
Status last verified
Nov 2024
First submitted
21 Jan 2024
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Al-Digheari A, Mahboub B, Tarraf H, Yucel T, Annesi-Maesano I, Doble A, Lahlou A, Tariq L, Aziz F, El Hasnaoui A. The clinical burden of allergic rhinitis in five Middle Eastern countries: results of the SNAPSHOT program. Allergy Asthma Clin Immunol. 2018 Nov 19;14:63. doi: 10.1186/s13223-018-0298-x. eCollection 2018.

    PubMed 30473712

  • Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780.

    PubMed 27434218

  • Cheng L, Chen J, Fu Q, He S, Li H, Liu Z, Tan G, Tao Z, Wang D, Wen W, Xu R, Xu Y, Yang Q, Zhang C, Zhang G, Zhang R, Zhang Y, Zhou B, Zhu D, Chen L, Cui X, Deng Y, Guo Z, Huang Z, Huang Z, Li H, Li J, Li W, Li Y, Xi L, Lou H, Lu M, Ouyang Y, Shi W, Tao X, Tian H, Wang C, Wang M, Wang N, Wang X, Xie H, Yu S, Zhao R, Zheng M, Zhou H, Zhu L, Zhang L. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jul;10(4):300-353. doi: 10.4168/aair.2018.10.4.300.

    PubMed 29949830

  • Ren Q, Ren L, Ren C, Liu X, Dong C, Zhang X. Platelet endothelial cell adhesion molecule-1 (PECAM1) plays a critical role in the maintenance of human vascular endothelial barrier function. Cell Biochem Funct. 2015 Dec;33(8):560-5. doi: 10.1002/cbf.3155. Epub 2015 Nov 25.

    PubMed 26607202

  • Soon AS, Chua JW, Becker DL. Connexins in endothelial barrier function - novel therapeutic targets countering vascular hyperpermeability. Thromb Haemost. 2016 Oct 28;116(5):852-867. doi: 10.1160/TH16-03-0210. Epub 2016 Aug 4.

    PubMed 27488046

  • Cong X, Kong W. Endothelial tight junctions and their regulatory signaling pathways in vascular homeostasis and disease. Cell Signal. 2020 Feb;66:109485. doi: 10.1016/j.cellsig.2019.109485. Epub 2019 Nov 23.

    PubMed 31770579

Questions about this trial

What is this clinical trial studying?

A study testing lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals) in people with Allergic Rhinitis, run by Cheng Lei at 2 sites in China.

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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rhinoconjunctivitis Quality of Life Questionnaire (time frame: baseline and 14 days). The study lists 3 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 NCT06709092, which also lists 6 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 29 Nov 2024.

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