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Showing 1-20 of 261 trials
NCT07436208
Soluble suppression of tumorigenicity 2 (sST2), a decoy receptor of interleukin-33 (IL-33), involved in allergic inflammation. Objectives: This study explored serum sST2 as a biomarker for disease activity and for predicting clinical response to sublingual immunotherapy (SLIT) in patients with house dust mite (HDM) induced AR. Methods: This study included 54 patients with moderate-to-severe AR (MSAR) and 54 healthy controls (HC). Serum sST2, total IgE, HDM-specific IgE, and eosinophil counts were measured. Serum levels of miR-223 were assayed using real-time PCR. Clinical severity was assessed using the total nasal symptom score (TNSS) and visual analogue scale (VAS). MSAR patients received SLIT for 6 months. Treatment response was defined by ≥30% reduction in symptom and medication scores.
NCT07427576
House dust mites are the main source of allergies in indoor environments. They are predominant in coastal areas, with the Canary Islands being the autonomous community with the highest percentage of patients with rhinoconjunctivitis due to sensitisation to these mites (94.7%). Immunotherapy is indicated for the treatment of allergic rhinoconjunctivitis and is capable of altering the natural course of allergic diseases. The aim of the study was to evaluate the efficacy and safety of Clustoid® Max Forte in the treatment of patients with respiratory allergy to Dermatophagoides/Blomia tropicalis.
NCT07308288
Respiratory allergic diseases, namely asthma and allergic rhinitis (AR), are among the most common chronic pediatric conditions with prevalence continuing to rise over last decades and are leading healthcare costs. Epidemiological trends show high rates in young children, aged under 10 years, significant comorbidity between conditions (asthma and AR), and a rising recognition of lifestyle's role in microbial, epithelial barrier and immune system dysfunction which collectively drive type 2-driven airway inflammation, the hallmark feature of allergic respiratory diseases. Strategies aiming to reduce allergy outcomes have included dietary interventions during the pediatric age with immunonutrition and postbiotics. Immunonutrition uses specific nutrients to support the immune system, while postbiotics use microbial-derived compounds to modulate microbiome, epithelial barrier and immune function, and they can work together by modulating the gut-immune axis to reduce inflammation and to promote immune tolerance also through epigenetic mechanisms. Vitamin D, DHA, quercetin, perilla frutescens, fructooligosaccharides and DHA have been indicated as promising food supplements for and effective immunonutrition action against allergy. Similarly, postbiotics-non-viable microbial preparations with demonstrated biological activity-such as heat-inactivated Lactobacillus rhamnosus GG (LGG) and the gut microbiome-derived metabolite butyrate have been shown to strengthen epithelial barrier integrity, modulate cytokine secretion, and promote regulatory immune responses. Collectively, these findings suggest that targeted nutritional or microbial-derived interventions capable of reinforcing epithelial barrier function and restoring regulatory immune pathways may offer a promising adjunctive strategy for pediatric allergic airway diseases. Despite the expanding mechanistic evidence, clinical trials evaluating multi-component immunomodulatory nutritional interventions in children with asthma or allergic rhinitis remain scarce, and the translational relevance of these mechanistic pathways has not yet been thoroughly tested in controlled pediatric studies. Based on this rationale, we designed a clinical study to evaluate the clinical and immunological effects of a multi-component supplement containing immunonutritional compounds and postbiotics focusing on symptom control and immunoregulatory biomarkers in PBMCs from children with allergic asthma and AR.
NCT06603935
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.
NCT05186025
The primary objective of this 5-year study is to demonstrate non-inferiority of children compared to adults by exploring long-term effectiveness after treatment with TA Bäume (trees) and TA Gräser (grass) following a perennial posology.
NCT01992835
After an allergen challenge, the allergic inflammatory response disappears spontaneously. The initiation of the resolution of the inflammatory response is now recognized as a dynamic process, involving active biochemical programs that enable inflamed tissues to return to homeostasis. Recent data established key roles of different specific lipid mediators in the endogenous counter-regulation of inflammation and activation of resolution. Only little is known about kinetics of these specialized pro-resolving lipid mediators during acute allergic inflammation. Therefore, the primary propose of our study is to characterize the temporal evolution of cellular inflammation and specific lipid mediators after allergen challenge.
NCT01425632
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and plasma concentrations of TAU-284.
NCT07308015
To observe the therapeutic effect of sodium hyaluronate adjustable nasal irrigator on various types of rhinitis sicca and compare it with the therapeutic effect of the commonly used physiological seawater nasal spray in clinical practice.
NCT05637710
AR is the most common respiratory disease worldwide and is clinically defined by the presence of nasal symptoms induced by exposure to allergens, particularly nasal obstruction and pruritus, runny nose and sneezing. The treatment purpose is to prevent or alleviate symptoms as safely and effectively as possible. Above all, it is recommended that patients avoid contact with allergens to which they are sensitive. However, this is often not enough, and pharmacological interventions are often required. H1 antihistamines (anti-H1) are considered first-line drugs in the treatment of AR1. These drugs effectively relieve symptoms of the immediate phase of AR, such as nasal pruritus, sneezing, runny nose and associated eye symptoms, and partially the nasal blockage characteristic of the late phase of the disease. Due to their excellent safety profile and therapeutic advantages in the treatment of AR, second-generation anti-H1 drugs, such as levocetirizine, should always be prioritized over older compounds in all age groups1. The combined administration of an antihistamine and an oral decongestant was shown to b more effective than the administration of an antihistamine alone for the relief of AR-associated nasal obstruction1. Levocetirizine is an active pharmaceutical ingredient (API) registered in the country as a monodrug for oral administration at a dose of 5mg. Pseudoephedrine is not marketed as a monodrug for oral use in our area, but it is registered in FDC with antihistamines, which is why there is no comparator arm treating with pseudoephedrine only. These products are widely used and their efficacy and safety are well known in daily clinical practice in the proposed indication. Once the absence of a pharmacokinetic interaction between levocetirizine and pseudoephedrine has been confirmed in relative bioavailability studies (RBA), this phase 3 study will be conducted in order to demonstrate the superiority of FDC levocetirizine 5mg / pseudoephedrine 240mg over levocetirizine 5mg administered alone in the symptomatic treatment of AR, particularly with regard to nasal obstruction. The registration seeks to provide a new effective and safe therapeutic option to address these cases.
NCT03570957
The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of MT-2990 in patients with Japanese cedar pollen-induced seasonal allergic rhinitis (JC-SAR). Additional objective of the study is to investigate the efficacy and pharmacodynamics profile of MT-2990 in an environmental exposure chamber (EEC) on Day 8, 29, 57, and 85.
NCT07266688
This study aims to evaluate the effectiveness and safety of Bactorinol® nasal spray, a medical device containing winterized Pistacia lentiscus oil, in adults with vasomotor rhinitis. Vasomotor rhinitis is a chronic condition characterized by nasal congestion, rhinorrhea, and impaired nasal airflow. In this multicenter, prospective, randomized, controlled clinical trial, 100 adult participants will be assigned in a 1:1 ratio to receive either Bactorinol® nasal spray or isotonic saline solution for 20 consecutive days. The primary objective is to determine whether Bactorinol® improves nasal airflow, measured by Peak Nasal Inspiratory Flow (PNIF). Secondary objectives include evaluating changes in symptoms and quality of life using the SNOT-22 questionnaire, assessing nasal cytology, and monitoring treatment compliance and adverse events. The results of this study may help identify a non-pharmacological, natural-extract-based treatment option for patients with vasomotor rhinitis.
NCT06732414
Background: Allergic or sinus diseases can affect the skin, sinuses, airways, and other parts of the body. Examples include pollen and environmental allergies, food allergies, asthma, and eczema. To learn more about how to prevent and treat these diseases, researchers need to study data, blood, fluid, and tissue samples from people affected by them. Objective: To collect data, blood, fluid, and tissue samples from people with allergic or sinus diseases. Eligibility: People aged 3 to 100 years with allergic or sinus diseases. Design: Participants will have at least one clinic visit, and most participants will have a baseline visit, annual visit, and an end of study visit. The duration of the study is 1 to 3 years. During the first clinic visit, the following procedures will be done to collect data, blood, fluid, and tissue samples: * Blood will be collected. * Cells and fluid may be collected from the inside of the nose using a long swab, and a small piece of skin may be scraped from inside the nose. * Skin cells will be collected by rubbing with a cotton swab. * A urine sample will be collected. * Allergy skin prick tests. Allergy-causing substances will be placed on the back or arm and the skin underneath gently scratched. If the participant is allergic to the substance, the skin may become red, itchy, and swollen locally ( at the site of the test). * Lung function test. Participants will breathe into a machine that measures the air moving in and out of their lungs. * If, as part of their routine care, participants are undergoing procedures such as having nasal polyps removed, skin tissue samples taken, or gastrointestinal biopsies, additional tissues may be collected for this study. * Participants will complete online questionnaires regarding their symptoms, health, and life. Participants may return for more visits for up to 3 years.
NCT06676111
To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions.
NCT05494346
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.
NCT06085963
Clinical efficacy and tolerability for allergen specific immunotherapy (AIT) with Itulazax (birch pollen extract tablet) is well established. Allergen challenges are used by clinicians to confirm correct diagnosis and by researchers to evaluate the efficacy of different interventions, eg. AIT. The challenge is performed by using a specific controlled administration schedule of an allergen product in the shock organ (nose, eye, or airway) and then monitor the result. Nasal Allergen Challenge (NAC) is the most common allergen challenge used. Aquagen SQ (birch pollen extract) has since decades been golden standard for this purpose, but production of this product ended 2019. Clinicians as well as researchers are now in need for an alternative product. To evaluate a new method for NAC would be of value from a clinical- and research perspective. From a Nordic perspective a NAC study with dissolved Itulazax would be of special interest since birch allergy is a dominant allergen in the region. In a recently published article it was shown that dissolved Grazax and Aquagen Phleum pratense gave comparable result used in grass allergic patients. Therefore, it seems reasonable to assume that the same method could be used with dissolved Itulazax. The aim of this clinical trial is to evaluate the feasibility of nasal allergen challenge tests with dissolved Itulazax tablets. The main benefit of this proposal is that the allergen composition of the provocation test product is the same as the final product to be treated with. This is likely to increase the treatment motivation of the patient. In addition, the dissolving process is easier for the physician compared to the dissolving of the previously used Aquagen.
NCT05191186
Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo
NCT07114107
This is a prospective study. It enrolls subjects with allergic rhinitis, with or without asthma, who have nasal congestion as the main symptom and meet the inclusion criteria, aiming to evaluate the efficacy and safety of acoustic vibration combined with an oscillating positive expiratory pressure device in the treatment of patients with nasal congestion. On the premise that subjects agree to use basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA), they are instructed to use the acoustic vibration therapy device and the oscillating positive expiratory pressure therapy device respectively, 3 times a day for 3 minutes each time. Indicators related to nasal congestion will be measured immediately after a single use, as well as at 2 weeks, 4 weeks, and 8 weeks of use, so as to monitor the improvement of nasal ventilation and accompanying symptoms in the subjects.
NCT06837233
The study is a multicenter, randomized, double-blind, placebo-controlled seamless and adaptive-designed phase IIb/III study encompassing a phase IIb and a phase III component. The phase IIb study, which is registered this time, is a dose-ranging component. The phase III study is a pivotal part of the overall research. The goal of this phase IIb study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray across various dosages and administration frequencies for treating adults with moderate to severe seasonal allergic rhinitis (SAR). Investigators will compare PG-011 nasal spray to a placebo (a look-alike substance that contains no drug) to see which dosage and frequency works to treat moderate to severe seasonal allergic rhinitis.
NCT04435990
A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.
NCT06920771
Rationale: Allergic rhinitis/rhinoconjunctivitis (ARC) is a global health problem, affecting 10-25% of the population. Allergen-specific immunotherapy is the only disease-modifying therapeutic option for subjects with house dust mites (HDM)-induced allergic rhinitis/rhinoconjunctivitis. This Phase 3 clinical study aims to demonstrate the effecacy of PURETHAL Mites (PM) Mixture subcutaneous immunotherapy (SCIT) compared to a placebo over one year of treatment in patients with moderate to severe HDM- induced allergic rhinitis/rhinoconjunctivitis (ARC), while also prioritizing the safety of the treatment. PM Mixture is a suspension of chemically modified extract from the house dust mites Dermatophagoides pteronyssinus (D. pter) and Dermatophagoides farinae (D. far), adsorbed to aluminium hydroxide. Modified extracts (allergoids) are associated with reduced allergenicity but with preserved immunogenicity. Based on the previous studies the dose of 0.5 mL of PM Mixture solution with concentration 50,000 AUeq/mL (allergen units in millilitre) was selected for this Phase 3 clinical study. Objectives: The primary objective is to assess the efficacy of PM Mixture 50,000 AUeq/mL (0.5 mL) SCIT based on an average Total Combined Rhinitis Score (TCRS), which will be compared between PM Mixture and placebo groups. The TCRS consists of rhinitis symptom score and medication score measured daily over the last 8 weeks of the 1 year treatment. Other secondary efficacy parameters will be compared between treatment groups to show efficacy: rhinitis symptom and medication scores separately as well as a combined symptom and medication score for nasal symptoms only (CSMS(n)); Total Combined Conductivities Score; nasal provocation test; immunological blood markers such as immunoglobulins E, G and G4; and Rhinitis Quality of Life Questionnaire (standardised) (RQLQ(S)). Trial design: This is a randomized, double-blind, placebo controlled multi-centre clinical trial where subjects are participating for about 14 months. Trial population: Patients (18-65 years of age) suffering from moderate to severe ARC induced by HDM with or without controlled asthma can be included in the study. The main criteria to evaluate the HDM allergy will be done by the following parameters: allergic medical history to HDM minimum 1 year; positive skin prick test and nasal provocation test HDM D. pter and/or D. far; certain level of allergen-specific immunoglobulin E to D. pter or D. far, and most importantly they should have sufficient rhinitis symptom score measured during 2 weeks at screening. Additionally patients should have sufficient lung functions confirmed by the spirometry, they may have asthma which should be controlled. Patients with a chronic or acute disease that might place the subject at an additional risk will not be included. Certain medications which can interfere with the study treatment or increase the health risks should be washed-out and can not be taken during the study. Approximately 920 HDM-allergic subjects will be screened in order after the screening period to enroll 552 subjects.