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NCT07419230
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.
NCT04648930
This was a multicenter, uncontrolled, open-label, special drug use study to investigate the safety and efficacy of Xolair by collecting data in its clinical setting in patients with severe to most severe seasonal allergic rhinitis aged ≥ 12 years and \< 18 years whose symptoms were inadequately controlled despite to conventional therapies and used Xolair.
NCT06907680
The goal of this clinical trial is to assess the efficacy and safety of M-Gard supplementation for alleviating the symptoms of allergic rhinitis.
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.
NCT05720455
This is a single group, Phase IV clinical trial to assess the safety and effectiveness of Allegra® D. This study will be conducted in participants with allergic rhinitis who are 12 years of age and above. The individual study duration for each participant would be approximately 16 days (maximum of 13 days intervention + a 3-day post intervention observation). There would be 4 study visits in which the last visit can be done either telephonically or on site. Safety events would be captured for the entire study duration. In addition, the effectiveness of the study drug would be assessed using Nasal symptom score (NSS) and Total symptom score (TSS).
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.
NCT07385495
Allergic conjunctivitis (AC) causes inflammation of the conjunctiva in response to environmental allergens, affecting a significant percentage of the world population and reducing quality of life. The pathophysiology is poorly understood, lacking effective treatments. MicroRNAs have potential for diagnosing and characterizing inflammatory diseases. This study aims to compare the expression profiles of inflammation-regulating microRNAs (miR-19, miR-23, miR-125b, miR-146a, and miR-155) in serum and tear samples from subjects with AC and healthy subjects to identify biomarkers and therapeutic targets.
NCT07380178
This study was conducted to see before and after treatment whether it provided improvement in the patient's clinical symptoms.
NCT01471184
The primary objective of this study is to assess the relative efficacy of Ectoin® Allergy Eye Drops and Ectoine® Allergy Nasal Spray compared to placebo, by evaluating Total Nasal Symptom Score (TNSS) and Total Ocular Symptom Score (TOSS). The secondary objectives are : * To evaluate the relative efficacy of Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal Spray compared to placebo by evaluating Total Non Nasal Symptom Score (TNNSS), congestion symptom scores, red eye symptom scores, watery eye symptom scores, itchy eye symptom scores, and by evaluating the mean cross-sectional area (MCA) using acoustic rhinometry (AcR). * To assess the change from baseline (post-EEC from pre-EEC) in inflammatory parameters of nasal secretions, comparing Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal Spray to placebo at each post-treatment visit.
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.
NCT06038279
This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses. This study will be conducted in two parts: Phase I single ascending dose (SAD) and Phase Ib multiple ascending dose (MAD).
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.
NCT06046391
Allergic rhinitis (AR) affects large population worldwide, the most commonly used medication include anti-histamine, nasal spray and anti-LTRAs inhibitors (leukotriene receptor antagonists), Even after those first-line treatment, there is still a large number of patient (\~20%) are not well/adequately controlled. Anti-IgE antibody has been approved to treat moderate to severe AR by PMDA/Japan in 2020, demonstrating the efficacy of IgE blockade in the treatment of allergic rhinitis. The current study presents a novel anti-IgE antibody (LP-003) with higher affinity to IgE, stronger efficacy and longer half-life.
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.
NCT07269509
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.