Clinical Research Directory

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.

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

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.

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.

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.

INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION

This prospective comparative study was conducted to evaluate the clinical efficacy, onset of action, and side-effect profiles of intranasal fluticasone propionate (FP) monotherapy and a fluticasone propionate-azelastine (MP-AzeFlu) combination in adult patients with moderate-to-severe allergic rhinitis. Patients with positive skin prick test results were randomly assigned to receive either FP monotherapy or MP-AzeFlu combination therapy. Symptom severity and quality of life were assessed at baseline, day 7, month 1, and month 2 using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a visual analog scale (VAS). The primary objective was to compare changes in quality-of-life scores between treatment groups. Secondary outcomes included onset of symptom relief and treatment-related sensory side effects.

Harnessing Digital Medicine to Improve Allergic Rhinitis Management in Primary Care (DMAR)

This study aims to evaluate the effectiveness of digital tools in managing allergic rhinitis (AR) in primary care settings. AR is a common condition that affects many people's quality of life. The study will test whether digital tools, such as the QHSLab platform, can help patients better control their symptoms, improve adherence to treatment, and enhance overall well-being. The trial will compare two groups: one using standard care and the other using both standard care and digital tools. Participants will be monitored over 12 months, and the study will measure changes in symptom severity, treatment adherence, quality of life, and healthcare usage. The study will also gather feedback from patients and healthcare providers about their experience with the digital tools. The digital tools used in this study are designed to help patients manage their AR more effectively by providing regular symptom assessments, medication reminders, and personalized feedback based on their health data. This summary ensures the information is clear and straightforward for patients, families, and healthcare providers while maintaining compliance with IRB guidelines.

Allergenic Extract Standardized Cat Hair AP in an Allergic Rhinitis Model.

The goal of this study is to learn if a cat allergen extract known as Allergenic Extract Standardized Cat Hair Acetone Precipitated (AP Cat) can induce allergic rhinitis (AR) in a nasal allergen challenge model in cat-allergic people. The main questions this study aims to answer are: 1. Does AP Cat induce nasal symptoms of allergic rhinitis in cat-allergic participants when delivered intranasally? 2. Does AP Cat reduce elements in the blood and nose that are known to be associated with allergies? Both allergic and non-allergic participants will be recruited into this study. Allergic participants will: * Be challenged with AP Cat via the Nasal Allergen Challenge (NAC), which involves administration of this allergen extract directly into the nose. * Have nasal fluid and blood samples collected at various timepoints up to 24 hours after exposure to the allergen in the NAC. * Visit the study site three separate times: 1. At screening (Visit 1), to determine eligibility to participate in this study 2. At the baseline NAC visit (Visit 2) 3. At the 24-hour post-NAC follow-up visit (Visit 3) * Complete nasal symptom questionnaires. * Complete a questionnaire about their regular exposure to cats. Non-allergic participants will: * Be challenged with AP Cat via the NAC, which involves administration of this allergen extract directly into the nose. * Have nasal fluid and blood samples collected at various timepoints up to 24 hours after exposure to the allergen in the NAC. * Visit the study site three separate times: 1. At screening (Visit 1), to determine eligibility to participate in this study 2. At the baseline NAC visit (Visit 2) 3. At the 24-hour post-NAC follow-up visit (Visit 3) * Complete nasal symptom questionnaires. This study will compare the nasal symptoms and allergic markers collected from the nasal fluid and blood samples between allergic and non-allergic participants at baseline and various timepoints post-NAC exposure.

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.

Implementation of an Allergic Rhinitis Severity Questionnaire in ENT Consultations

Allergic rhinitis is a very common condition (affecting 1 in 5 people in Europe) and a costly one for society (direct and indirect costs). Symptoms vary depending on the time of year, and treatments are primarily symptomatic, with follow-up in ENT consultations. Scientific societies (EAACI, FDA, EMA) recommend using a universal tool (severity score) (the CSMS score, SCST in French) to monitor severity and follow-up, and to obtain consistent data that can be extrapolated to other scientific data (meta-analyses). Therefore, investigators in the ENT department use this SCST score (as well as others such as the SNOT 22 score) to assess the severity of allergic rhinitis in our patients and its progression. Tbe investigators wish to confirm the acceptability of this tool for patients, and the statistical value of its properties.

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.

A Prospective, Randomized, Controlled Study Comparing the Efficacy of Intranasal Corticosteroids (INCS) Combined With Intranasal Antihistamines (INAH) and INCS Combined With Oral Antihistamines (OAH) in the Treatment of Moderate to Severe Allergic Rhinitis Symptoms

Through prospective exploration of the efficacy of intranasal corticosteroids (INCS) combined with intranasal antihistamines (INAH) and INCS combined with oral antihistamines (OAH) in treating moderate to severe allergic rhinitis symptoms, this study aims to provide evidence-based medical evidence for the standardized treatment of patients with moderate to severe allergic rhinitis accompanied by typical nasal and ocular symptoms.

Laser Posterior Nasal Nerve Neurolysis

This clinical trial aims to learn if laser posterior nasal nerve neurolysis can treat chronic rhinitis in adults. It will also learn about the safety of laser posterior nasal nerve neurolysis. The main questions it aims to answer are: 1. Does laser posterior nasal nerve neurolysis improve chronic rhinitis symptoms? 2. What side-effects or complications do participants have after laser posterior nasal nerve neurolysis? Researchers will compare laser posterior nasal nerve neurolysis to a placebo(a sham surgery with the same device and sound to see if laser posterior nasal nerve neurolysis works to treat chronic rhinitis. Participants will 1. Receive laser posterior nasal nerve neurolysis in the office as local anesthesia surgery. 2. Visit the clinic in the first week, first month, and 3rd months after the surgery. 3. Record their symptom scores before the surgery and during each follow-up visit.

ClimAIr: AI to Assess the Impact of Pollution and Climate on Respiratory Health in Europe

The ClimAIr project will expand the evidence-based understanding of climate change, air pollution, and non-communicable respiratory diseases by using Artificial Intelligence (AI) tools. It will gather data on greenhouse gases levels and disaster risks, information on serious air pollutants and respiratory diseases' prevalence. The AI powered tools will be employed to generate better intervention methods and improve public health outcomes. Federated Learning (FL) will be used to develop AI models to protect patients' privacy. By raising public awareness and delivering the ClimAIr tool - specifically designed to health workers, urban planners and policy makers - the project aims to influence policy decisions, promote healthier environments, and reduce respiratory diseases in Europe, which will be tested and validated the ClimAIr tool in specific municipalities that are part of the project. ClimAIr draws on a consortium of 21 partners from 15 European countries, including carefully selected health centres across Europe - in Spain, Luxembourg, Ukraine, Italy, France, Germany, Greece, Romania and Poland - focused on respiratory diseases, which will provide disease data and explore metabolic routes of the studied contaminants/diseases. ClimAIr is composed of an interdisciplinary team formed by research centres, ethical AI and modelling experts, SSH specialists, municipal governance, and a Communication \& Dissemination (C\&D) expert team dedicated to achieving and spread the results of the project.

Evaluation of the Efficacy and Safety of an Intensified Strategy of Intratonsillar Immunotherapy (ITIT) for Allergic Rhinitis: A Multicenter, Randomized, Double-blind, Controlled Trial

This is a multicenter, randomized, double-blind, controlled trial to evaluate the efficacy and safety of an enhanced strategy of allergen-specific immunotherapy (ITIT) in the treatment of allergic rhinitis. By recording the changes in CSMS from baseline to post-treatment in the subjects and the incidence of adverse reactions after treatment, the differences in efficacy and safety between the patients who received the basic three doses and those who received booster injections were compared. Furthermore, the impact of different booster strategies on long-term efficacy was compared to optimize the injection strategy. At the same time, the influence of different administration procedures on the immune response was evaluated.

Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays. The main questions it aims to answer are: * Efficacy, * Safety, * Usage, * Satisfaction, in real-life usage among infants, children, adults and pregnant or breastfeeding women suffering from acute and chronic sinonasal pathologies. The 4 medical devices under investigation will be used in accordance with their intended use, target populations and medical indications.