Clinical Research Directory

Sphenopalatine Ganglion Acupuncture for Allergic Rhinitis

Allergic rhinitis can cause sneezing, a runny or blocked nose, and nasal itching, which may affect daily activities and quality of life. Nasal corticosteroid sprays are commonly used to control these symptoms, but some people may still have bothersome symptoms. The purpose of this study is to find out whether adding sphenopalatine ganglion acupuncture to mometasone furoate nasal spray can improve allergic rhinitis symptoms more than using the nasal spray alone, and to evaluate the safety of this treatment. Adults with moderate-to-severe perennial allergic rhinitis will be randomly assigned to one of two treatment groups. Both groups will use mometasone furoate nasal spray for 4 weeks. Participants in one group will also receive sphenopalatine ganglion acupuncture twice a week for 4 weeks. Researchers will compare changes in nasal symptoms, quality of life, use of rescue medication, clinical examination findings, and adverse events between the two groups. Participants will also be followed after treatment to assess whether the treatment effects are maintained.

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.

Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction

The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.

AI-Guided Ultrasound Needling of Xinwu Point for Allergic Rhinitis

This study evaluated a new way to perform acupuncture at a deep point called the Xinwu point (sphenopalatine ganglion) for allergic rhinitis (hay fever-like nasal allergy). The point is hard to reach with the usual blind needling method. Artificial intelligence (AI) with real-time ultrasound images was used to help the acupuncturist see nearby structures and guide the needle. Sixty adults were randomly assigned to AI-guided needling or usual blind needling. Both groups received the same acupuncture schedule: both sides of the face, once a week, for six sessions. The primary aim was to measure how accurately the needle reached the target. Side effects, nasal symptom scores, overall improvement, and how acceptable participants found the procedure were also recorded.

Effect of AI(Artificial Intelligence)-Based Storytelling Video on Anxiety and Fear During Skin Prick Test in Children

This study evaluates the effectiveness of an AI-generated therapeutic storytelling video on pre-procedural anxiety and fear levels in children aged 4 to 10 years undergoing their first Skin Prick Test (SPT). The study aims to determine if watching a cognitive preparation video at home prior to the appointment reduces anxiety compared to standard care. Participants will be randomized into two groups: an intervention group watching the AI-generated video and a control group receiving standard clinic care

Study of Yupingfeng Powder Treating Allergic Rhinitis (AR)

Rhinitis is broadly defined as inflammation of the nasal mucosa. It is a common disorder that affects up to 40% of the population. Allergic rhinitis (AR) is the most common type of chronic rhinitis, affecting 10-20% of the population, and evidence suggests that the prevalence of the disorder is increasing. AR is a very common clinical disease that can occur at any age. Severe allergic rhinitis has been associated with significant impairments in quality of life, sleep and work performance. Nowadays, the main treatment for allergic rhinitis is the use of western medicine, such as steroids and antihistamines. However, many clinical studies have found that the curative effect of western medicine is often not ideal. From the perspective of Chinese medicine, this disease is resulted from the deficiency of Qi and Yang Qi in the lungs, spleen and kidneys. Therefore, according to Chinese medicine theory, tonifying lung and spleen qi is the treatment principle for AR patients. Among different Chinese herbal formulae for AR, Yupingfeng Powder is commonly used for allergic diseases and in AR patients, due to its warm nature and able to improve the functions of the lungs and spleen. Yupingfeng Powder can improve symptoms and quality of life, as well as decrease the levels of interleukin and IgE in AR patients. This study will use Yupingfeng Powder with variation to evaluate its effectiveness and safety in treating AR. Hence, a double-blind, randomized, placebo-controlled clinical trial design with strong scientific rigor will be employed in this study, and it would be able to provide robust clinical evidence on the efficacy and safety of Yupingfeng Powder with variation for AR. Recruited subjects will be randomly assigned to receive orally Yupingfeng Powder with variation or placebo twice a day for 8 weeks, with follow-up for another 8 weeks after stopping the treatment to observe the duration of efficacy. In our previous study, it is shown that Yupingfeng Powder can significantly improve the symptoms of AR, and there was no serious adverse event reported by the subjects. And in this project, we modify the design of the trial to further investigate the efficacy of Yupingfeng Powder with variation for AR patients with a larger sample size.

Validation of an Allergic Rhinitis Control Test in Children

Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.

Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis

The ragweed Ambrosia artemisiifolia is spreading in northern Europe due to climate change. The pollen are considered highly allergenic and might trigger allergy symptoms at much lower concentrations than e.g. grass or birch pollen. This study aims to determine threshold concentrations for ragweed and birch pollen in patients with seasonal allergic rhinitis. Participants will be exposed in an allergen challenge chamber that was technically modified to maintain very low and stable pollen concentrations for several hours. The study design is adaptive, where the pollen concentrations are escalated or de-escalated based on interim analysis of resulting allergic symptoms.

Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine

Phase IIIb , longitudinal, multicenter, randomized, double-blind, to evaluate efficacy and safety of the fixed-dose combination of Desloratadine 5 mg / Betamethasone 0.25 mg versus Desloratadine 5 mg monotherapy as treatment for symptoms associated with allergic rhinitis.

A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.

Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma

To assess the impact of SQ SLIT-tablets (SQ Grass SLIT-tablet and SQ HDM SLIT-tablet) in Danish and Swedish allergic rhinitis (AR) patients, with or without asthma, between 2007-2020.

Observational Study of RHINOSEDAL in Acute Nasal Obstruction

This prospective, multicenter, national, observational, non-interventional post-market clinical follow-up study evaluates the performance and safety of RHINOSEDAL in children and adults presenting with acute nasal obstruction associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis. Patients prescribed RHINOSEDAL in routine care will be followed for 6 ±1 days using patient-reported outcome measures including the NOSE score.

The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa

The aim of this study to compare the efficacy of Rhinophototherapy to Intranasal Corticosteroids on the the nasal mucosa of allergic rhinitis patients. The main question to answer is: Does intranasal phototherapy reduce inflammation in the tissue biopsy of the inferior turbinate mucosa compared to intranasal steroids? The hypothesis for this study is Intranasal phototherapy will reduce mucosal inflammation without mucosal damage and is comparable to intranasal steroids in allergic rhinitis patients

Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis

This study is designed to evaluate the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to saline spray in adults with Seasonal Allergic Rhinitis (SAR). PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to form a mechanical barrier on the nasal mucosa and reduce contact between airborne allergens and the nasal lining. This is a prospective, randomized, single-blind, multi-center clinical investigation in up to 120 participants at up to 8 sites in the United States. Eligible participants with a history of seasonal allergic rhinitis will be randomized in a 1:1 ratio to receive either PL-14 Allergy Blocker or Ayr® Saline Nasal Mist for up to 30 days. The study will evaluate the effect of PL-14 Allergy Blocker on nasal allergy symptoms, quality of life, rescue medication use, and symptom-free days. Safety and local tolerability assessments will also be performed throughout this study period.

Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid

This study is a prospective randomized controlled trial that aims to enroll 158 patients diagnosed with chronic hypertrophic rhinitis who are candidates for inferior turbinate surgery. Participants will be randomly assigned to either the "standard group" or the "PDA group." The standard group will receive conventional shared decision-making (SDM) explanations using verbal and visual aids, while the PDA group will additionally receive a printed patient decision aid (PDA) to assist in evaluating the pros and cons of each surgical option. The study will assess patients' decision certainty and decision regret using the SURE scale and the Decision Regret Scale (DRS), respectively, administered before surgery and one month postoperatively. Surgical satisfaction and outcomes will also be evaluated using pre- and postoperative symptom questionnaires. All data will be collected and analyzed by blinded outcome assessors to ensure objectivity. This study involves no invasive procedures and is classified as a low-risk behavioral study. The primary aim is to optimize clinical decision-making processes for patients with chronic hypertrophic rhinitis considering surgical intervention in the otolaryngology setting.

EmoTIChealth: Promoting Adolescent Health Through a Serious Game.

The intervention program targets adolescents between 12 and 16 years of age. The intervention program is designed for adolescents during a critical developmental stage marked by significant life transitions, where building strong personal resources and receiving psychological support is essential to foster socioemotional skills and overall well-being. The serious game aims to promote psycho-emotional health in the general adolescent population, supporting healthy development and preventing future emotional difficulties. At the same time, it incorporates specific modules for adolescents living with chronic conditions such as asthma, food allergy, type 1 diabetes, and allergic rhinitis, who may face additional risks of psychological challenges that can complicate treatment and prognosis. By combining universal health promotion with tailored support, the program addresses both the needs of healthy adolescents and those with chronic illnesses. The platform integrates digital and technological tools for dynamic and personalized intervention. Artificial intelligence adapts activities and feedback to each participant's socio-demographic profile and evolving needs, this supports directly in participants' daily lives and natural environments, making the experience more relevant and impactful. The serious game, proven effective in engaging young people, goes beyond traditional psychoeducation by creating an interactive environment where adolescents develop socio-emotional competencies, resilience, and health-related knowledge. Through its six thematic areas, the game promotes overall well-being and healthy habits, while its condition-specific modules provide targeted guidance and coping strategies for asthma, food allergies, type 1 diabetes, and allergic rhinitis.

Effect of the Probiotic ES1 and Its Inactivated Form (HT-ES1) Over Symptomatology Asociated With Allergic Rhinitis

Allergic rhinitis (AR) is a health problem characterised by an inflammatory reaction in the nasal mucosa mediated by immunoglobulin (Ig) E and resulting from exposure to environmental allergens, such as pollen and dust mites. AR symptoms can significantly affect the quality of life of patients suffering from AR, causing substantial direct health care costs and indirect costs due to absenteeism from work. The effects of pharmacological treatments are not always fully effective and have adverse effects, resulting in a significant proportion of AR patients continuing to experience symptoms or being dissatisfied. Considering the relationship between AR and intestinal microbiota (IM), the use of probiotics, live microorganisms that, when consumed in adequate amounts, confer beneficial effects on the host, emerges as a potential strategy to prevent or treat certain allergies. There are different mechanisms of action by which probiotics may exert their effects on the treatment or prevention of allergies through modulation of the immune system and stimulation of tolerance. Probiotics promote a change in IM. In addition, probiotics stimulate gut-associated lymphoid tissue, modulating inflammation and immune reactions present in AR, promoting a more favourable profile by increasing the production of the modulatory cytokines IL-10 and TGFβ by Treg cells. Probiotics can restore the Th1:Th2 balance by inducing Th1 responses through the production of IL-12 and interferon (IFN)-γ, or by suppressing Th2 responses through the depletion of IL-4. In addition, probiotics may exert immunomodulatory effects through stimulating mucosal IgA production. The hypothesis of the present study is that supplementation with the probiotic Bifidobacterium longum ES1 and/or with the heat treated version of ES1 will decrease the symptomatology associated with AR and improve the quality of life of individuals by modulating IM and potentiating Treg cells and the Th1 response. The main objective of the present study is to determine the effects of supplementation with the probiotic Bifidobacterium longum ES1 and the heat treated version of ES1 (HT-ES1) on the symptoms associated with AR. The secondary objectives of the study are to determine the effects of the treatments over: 1) Quality of life; 2) Blood immunological markers (IFN-γ, IL-12, IL-10, TGF-β, IgE, IL-4, IL-13, IL-19 and IL-8); 3) Faecal immunological marker IgA; 4)Faecal microbiota composition.

Environmental Exposure Unit Trial in Subjects With Ragweed-induced Allergic Rhinitis

The purpose of this trial is to see how well an experimental nasal spray, called INI-2004, works for those with allergy symptoms to ragweed. This nasal spray will compare how well 500mcg of INI-2004, given once per week for 4 weeks, works at reducing ragweed allergy symptoms in an Environmental Exposure Unit (EEU), compared to placebo.

The Effect of Oral Probiotics on Allergic Rhinitis Symptoms and the Quality of Life

Allergic rhinitis (AR), also known as nasal allergy, hay fever or seasonal allergic rhinitis, is an inflammatory condition of the nasal passages caused by the immune system's response to allergens in the air. Symptoms include runny or blocked nose, nasal itching, sneezing, and red, itchy, and watery eyes. These symptoms typically occur within minutes of exposure to allergens and can affect sleep, work productivity, and concentration during learning. Many patients with allergic rhinitis also suffer from conditions such as asthma, allergic conjunctivitis, or atopic dermatitis.Symptoms in the majority of patients tend to recur and persist over time. While medication can alleviate the symptoms, complete cure is challenging to achieve. Probiotics are generally defined as microorganisms that, when ingested, provide beneficial effects to the host. They primarily consist of bacteria that produce lactic acid, including Lactobacilli, Bifidobacteria, and Saccharomyces boulardii. One known mechanism underlying allergic diseases is the overactivation of Th2 cells, leading to an imbalance in the Th1/Th2 ratio. Previous research has explored whether the use of probiotics can prevent allergic diseases. Numbers of studies indicate that probiotics have the ability to modulate the immune system by increasing anti-inflammatory cytokines such as IFN-γ, IL-10, and IL-12 to enhance Th1 cell activity. Simultaneously, they suppress pro-inflammatory cytokines like IL-4, IL-5, and IL-13, inhibiting excessive Th2 activation and restoring Th1/Th2 balance to improve symptoms. Current evidence from clinical randomized controlled trials suggests that supplementation with probiotics during pregnancy and early infancy can prevent allergies or the development of more severe allergic conditions. However, regarding AR, current research has confirmed that probiotic consumption can improve the quality of life and the severity of nasal symptoms (measured by PRQLQ and TNSS) in AR patients. Nevertheless, the efficacy of regulating AR varies based on different strains or species of probiotics used. This project aims to select probiotic strains that enhance the function of regulatory T cells (Treg cells), thereby promoting the secretion of Th1 cell cytokines IL-12 and IFN-γ to assist in achieving Th1/Th2 immune balance. This approach aims to reduce specific immunoglobulin E (IgE) levels and achieve an anti-inflammatory effect, thereby improving the regulation of allergic reactions within patients' bodies.

Dietary Intervention on Atopy

Diet is a key determinant of overall health, with growing evidence associating dietary patterns with allergic diseases. Among these, atopic dermatitis (AD) is of particular interest as it often represents the earliest manifestation of the atopic triad. Investigating dietary interventions in AD therefore provides a relevant model to better understand how diet may influence the onset and progression of allergic disease more broadly.

Evaluation of a Digital Tool to Improve Aeroallergen Immunotherapy Adherence. NavigAITme Project

Aaeroallergen Immunotherapy (AIT) is indicated in the treatment of allergic rhinitis and asthma, and has shown efficacy to control symptoms and induce immunomodulatory changes that support post discontinuation efficacy. Data from clinical trials provides founding for its efficacy and safety profile, but the therapy needs to be withheld for a minimum of 3 years, with modalities that imply daily or near daily administration of a sublingual extract, or subcutaneous injections, every 4 to 6 weeks. This treatment regimen often faces other limitations such as cost, patient´s lack of knowledge regarding efficacy/safety, or potentiality of adverse reactions. These factors have been pointed out as main reasons for a reported low level of treatment adherence in real life. While overall literature data on treatment adherence ranges widely, from 6% to 93% of patients finalising the minimum of 3 years, current data from precise German registries inform of persistence at 3 years being very low, varying from 5.2% to 18.2% with differences depending on extract, route and patient´s age. Surprisingly, even if the Scientific community acknowledges patient adherence as a very relevant weak point, there´s paucity of structured strategies to tackle this issue, and those available, have mostly been developed in single centers, for periods below the 3 years of AIT recommended duration. In the era of technology, and with the spreading of mobile applications (App), new approaches are currently ongoing to counteract this important drawback . In this landscape, this study aims at creating a new App that will be thoroughly tested in a prospective long-term randomized trial, to improve AIT persistence.

Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma

The goal of this clinical trial is to evaluate the safety and tolerability of intralymphatic immunotherapy (ILIT) with ALUTARD SQ Felis domesticus in patients with cat allergy-induced allergic rhinitis and asthma. The main questions it aims to answer are: Is ILIT with ALUTARD SQ Felis domesticus safe and well tolerated? What immunological responses play a role in ILIT? Researchers will compare the effects of ILIT to existing subcutaneous immunotherapy (SCIT) approaches to assess safety, tolerability, immunogenicity, and efficacy. Participants will: Receive 3-4 ILIT injections of ALUTARD SQ Felis domesticus into an inguinal lymph node, guided by ultrasound. Undergo safety monitoring, including WAO guidelines for systemic allergic reactions and tryptase measurement. Complete lung function tests, questionnaires, and a modified nasal provocation test to evaluate asthma effects and treatment efficacy. Provide blood samples for ImmunoCAP and basophil activation testing using CAST ELISA. Inclusion criteria: Adults aged 18-65 with cat-dander-induced allergic rhinitis and asthma. Exclusion criteria: Hypersensitivity to treatment components, systemic steroid use, uncontrolled asthma (FEV1 \< 70%), recent severe asthma exacerbations, or serious comorbidities. The study aims to generate data to inform future efficacy trials.

Safety and Efficacy of Small Extracellular Vesicles Nebulizer in Patients With Allergic Rhinitis Complicated With Asthma

This trial aims to evaluate the safety, tolerability and efficacy of hUC-MSC-sEV-002 nebulizer in patients with allergic rhinitis and asthma. It consists of two parts: ① Single-center dose exploration (The Affiliated Hospital of Qingdao University): A 3+3 escalation design will test three doses (1×10⁸, 1×10⁹, 1×10¹⁰ particles/mL) to determine the maximum tolerated dose (MTD).Three subjects will be enrolled in each dose group. If no Dose-Limiting Toxicity (DLT) is observed among the 3 subjects, the study may proceed to the next dose exploration. If 1 out of the 3 subjects experiences DLT, an additional 3 subjects will be enrolled in the same dose group; the study may move to the next dose exploration only if no DLT is observed in these additional 3 subjects. If more than 1 out of the 3 subjects develops DLT, the previous dose group will be defined as the MTD. A total of at least 9 and at most 18 subjects will be recruited for this clinical trial. ② Multi-center case expansion: Participants will be randomized 2:1 to hUC-MSC-sEV-002 or placebo groups for efficacy comparison.Eligibility criteria: 18-60 years old; moderate-to-severe allergic rhinitis (ARIA guidelines) with positive inhaled allergen skin test; asthma diagnosed per GINA 2022; signed informed consent.Intervention: Nebulization once daily (5 times/week, 2 weeks, 10 doses total). Follow-up visits at baseline, Week 2, 4, 12, 24, including symptom scales, lung function tests, nasal endoscopy, nasal exhaled nitric oxide test, chest X-ray, blood tests, and electrocardiogram. The trial is approved by the Medical Ethics Committee of The Affiliated Hospital of Qingdao University (No. QYFYEC2025-192). Participants may withdraw anytime without affecting medical care. Study period: Aug 2025-Aug 2027. Sample size: 9-18 for Part 1; Part 2 size based on Part 1 results.

Free Diving Breathing Training in Allergic Rhinitis

The purpose of this study was to investigate the effects of diver-style breathing training on symptoms, pulmonary function, and respiratory muscle, in patients with allergic rhinitis.