Allergy encompasses a range of immune system responses to various substances, commonly involving the skin, respiratory system, or digestive tract. Clinical trials in allergy often evaluate new treatment approaches and strategies to improve symptom ma...
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Found 505 Actively Recruiting clinical trials
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This trial tests whether handing patients a combination inhaler as they leave the emergency room reduces how often their asthma flares again over the following three months. The reasoning starts with a gap in current practice. Asthma attacks send about two million people to US emergency departments each year. Most are treated and sent home, but roughly one in six comes back for more care on the same episode. Adding an inhaled steroid at discharge has looked promising since a 2000 Cochrane analysis of three trials, where the benefit was real but fell just short of statistical significance. Even so, uptake never took hold. Emergency clinicians hesitate to start what feels like a lifelong maintenance drug, and patients tend to give up on a steroid-only inhaler because it does nothing for symptoms in the moment compared with their familiar albuterol. Airsupra sidesteps both objections by combining albuterol and budesonide in a single device, which makes the emergency department a plausible place to start inhaled steroid therapy for the first time. Rather than randomizing individual patients, the study randomizes hospitals. Thirty emergency departments are split into two groups of fifteen, balanced by US region so the halves look alike at baseline. At intervention sites, enrolled patients go home on a short oral steroid course, such as prednisone 50 mg daily for five days, plus Airsupra to use as their rescue inhaler. Control sites treat patients however they normally would. Everyone receives a short asthma education handout. Enrollment runs through the Multicenter Asthma Research Collaboration, part of the Emergency Medicine Network founded in 1996 for exactly this kind of research. Massachusetts General Hospital coordinates the study from Boston but does not enroll patients itself. In broad terms, participants are adults aged 18 to 54 whose emergency physician has decided to discharge them on a short steroid course. Data collection happens on two tracks. In the emergency department, staff conduct a brief structured interview and a focused chart review using instruments developed for earlier asthma studies, entering everything into a central REDCap database. Afterward, patients are contacted at about three, six, and twelve weeks, usually by phone and sometimes by text, to discuss symptoms, medication use, and any side effects, with asthma control scored on a ten-item questionnaire called the AIRQ. Separately, patients sign releases so the Boston team can gather medical records covering the year before enrollment and the three months after, pulled from the enrolling hospital, the primary care provider, and any allergist or pulmonologist involved. Those records are what confirm repeat flares and document what medications patients are taking at the three-month mark. The main question is recurrence, meaning any urgent or unscheduled visit to a clinician for worsening asthma within three months of the original emergency visit. That is deliberately broader than the usual three-week relapse window, since symptoms typically settle within one to two weeks while the underlying inflammation takes closer to three. Nobody knows the true recurrence rate in this population, but the investigators expect around 33% under usual care, combining early relapses with additional flares across the autumn and winter weeks that follow. Asthma control at three months is the leading secondary question, alongside three-week relapse and whether patients start Airsupra at any point during follow-up. On the statistical side, recurrence is analyzed as time-to-event data, unadjusted and then adjusted for demographics such as age, sex, race and ethnicity, and insurance, plus any clinical factor showing an association at P<0.20. Three-month asthma control is compared with a t-test or Mann-Whitney U-test, and repeated measures arent needed because baseline control is meaningless during an active attack. There is no interim analysis, given the short enrollment period and Airsupras established safety record. Detecting a one-third reduction in recurrence, 22% versus 33%, requires 1,290 patients. Allowing for 70% follow-up, the target was raised to 1,860, or 930 per arm and 62 per site. Based on three decades of experience with this network, each site should reach that number within a four to five month enrollment window running from August to December.
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The purpose is to learn whether the over-the-counter amino acid supplement 5-hydroxytryptophan 5HTP, isolated from the plant Griffonia Simplifolia, can reduce allergic lung responses, improve lung function, and reduce anxiety and depression symptoms in children with allergic asthma. Participants will be randomly assigned to receive either 5HTP or a placebo and will later crossover to the other group. There are 5 study visits over about 12 weeks. The primary outcome is the change in FEV1. The investigators anticipate that 5HTP at the proposed doses will improve lung function as seen in preclinical studies using clinically relevant 5HTP. Other outcomes include blood eosinophil counts, eosinophil numbers in nasal fluid, lung inflammation, and changes in anxiety and depression scores measured using CES-DC and SCARED questionnaires. The study also examines whether 5HTP increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid 5-HIAA, and dopamine. The results have the potential to influence approaches to improve lung function and asthma-associated anxiety and depression.
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This prospective, open-label, multicenter, single-arm, non-interventional, observational surveillance is designed to assess the safety and effectiveness of Atectura inhalation capsule for up to 24 weeks under routine clinical practice. Three different doses of Atectura inhalation capsule will be prescribed via Breezhaler according to the approved label information in Korea. No additional diagnostic or monitoring procedures will be conducted specifically for this study.
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Researchers are evaluating the safety and effectiveness of SHR-1819 injection in treating adults with seasonal allergic rhinitis, a condition causing nasal allergy symptoms during pollen seasons. This phase II study is randomized, double-blind, and placebo-controlled, aiming to understand how the drug affects nasal symptoms and its behavior in the body. Participants are randomly assigned to receive one of two doses of SHR-1819 injection or a placebo. The study includes a treatment period lasting up to 4 weeks, where the impact on nasal symptoms is closely monitored. The trial also tracks safety by recording any adverse events for up to 12 weeks. Throughout the study, participants will complete daily symptom diaries and undergo assessments to measure changes in nasal symptoms using a total nasal symptom score. Researchers will collect data on how the drug is processed in the body and monitor participants safety. The total participation time may extend beyond the treatment period to capture all necessary outcome and safety information.
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Healthy Volunteer
The PALMIRE project is a prospective, monocentric study conducted at the University Hospital of Reims, France, involving patients diagnosed with chronic inflammatory pulmonary diseases including asthma, chronic obstructive pulmonary disease COPD, bronchiectasis, cystic fibrosis CF, primary ciliary dyskinesia PCD, and interstitial lung diseases ILD. These diseases are characterized by lung inflammation and remodelling, with highly variable clinical, functional, microbiological, biological, pathological, and prognostic features. The study aims to analyze phenotypic characteristics, including clinical, demographic, biological, morphological, pathological, and microbiological features, together with respiratory exposures and underlying mechanisms involving airway epithelium and inflammation processes. It also considers shared phenotypic traits between different diseases and the coexistence of components of several diagnoses in the same patient, which may suggest shared underlying mechanisms and possible therapeutic targets beyond the initial medical diagnosis.
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Healthy Volunteer
Researchers are comparing how two different forms of the study medicine GSK5784283 are processed in the bodies of healthy adults. This phase 1 study aims to understand the pharmacokinetics of GSK5784283, evaluating its safety, how well it is tolerated, and whether the two formulations behave similarly in the body. Participants will receive one of two versions of GSK5784283 by injection. The study is randomized and parallel in design, meaning participants are assigned to either the test or reference formulation without switching. The research includes monitoring blood levels of the drug over time to assess concentration and exposure. Participants will be involved in regular monitoring up to 253 days after dosing. This includes blood tests to measure drug levels, assessments for side effects or adverse events, laboratory tests, vital signs, and heart monitoring using ECGs. Researchers will also check for immune responses to the drug through antibody testing, ensuring comprehensive safety and effectiveness evaluations during the study period.
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Healthy Volunteer
The aim is to assess how closely international asthma guidelines agree in diagnosing asthma and to explore additional evidence of airways disease using physiologic criteria such as impulse oscillometry IOS, which is not included in current guidelines but is available through the Portsmouth lung function service. Asthma diagnosis is based on indicators such as airflow obstruction, airway sensitivity, and inflammation, but guidelines from NICE, GINA, and BTSSIGN use different diagnostic criteria, which can lead to inconsistencies in identifying patients with asthma. IOS is a simple, non-invasive lung function test that may improve the accuracy and ease of asthma diagnosis, although evidence for its use in adults remains limited. Routine outpatient lung function data from patients attending the severe asthma service at Queen Alexandra Hospital in Portsmouth will be analysed using an opt-out consent process. The analysis will focus on the usefulness of IOS compared with other lung function indices in diagnosing asthma. The findings may help refine asthma diagnostic methods and potentially expand the diagnostic toolkit to include IOS, improving the precision and ease of asthma diagnosis and management.
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Healthy Volunteer
This research observes children who took part in the TEMPO clinical trial during their first year of life to understand if their early feeding patterns affect the development of allergies or infections in childhood. The study follows these children up to 7.5 years to gather information on allergic symptoms, infections, and related medical care. It is an observational study without additional treatments or interventions. Participants complete self-administered digital questionnaires every three months using a smartphone, tablet, or computer. These questionnaires collect data on allergies, infections, medication use, medical device use, hospitalizations, and emergency room visits. The study is entirely virtual and decentralized, allowing families to participate remotely. Throughout the study, parents provide information via regular online questionnaires, helping researchers track their childs health over time. The main measurements include parent-reported symptoms, medication or device use, and healthcare visits related to allergies and infections. The study runs until March 2029 and includes children aged 3 to 10 years who completed the original TEMPO study.
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Researchers are investigating the long-term outcomes of children and young people who completed an 18-month course of oral immunotherapy OIT for peanut, egg, or milk allergy. The study aims to compare changes in health-related quality of life HRQL up to 5-15 years after stopping OIT, focusing on participants who achieved remission and those who did not. This observational study involves participants from four earlier clinical trials related to OIT treatment for these allergies. Participants will attend one follow-up visit where several tests and evaluations will take place. These include a blood test to measure specific immunoglobulin E sIgE levels related to peanut, egg, or milk allergies, and a skin prick test to assess allergy status using various extracts like histamine, saline, house dust mite, rye grass, and the relevant food allergen. Blood collection may be via venipuncture or fingerprick depending on feasibility. Plasma and blood cells will be stored for future research. During the single study visit, participants will complete allergy questionnaires, and blood and skin tests will be conducted to gather data on immune markers and allergy status. Researchers will measure changes in HRQL and the incidence and severity of allergic reactions over the years following OIT. The visit is expected to last about two hours, and results will help understand the long-term effects of OIT on food allergy remission and quality of life.
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Healthy Volunteer
Eosinophils are a type of white blood cell that can cause damage to the heart, nerves, and other organs when their levels are elevated, as seen in hypereosinophilic syndrome HES. Some people have a hereditary form called familial eosinophilia FE. This research aims to study FE, its genetic causes, damage mechanisms, and disease markers to better understand the disease and support the development of less toxic treatments. Approximately 50 adults and children from a family with FE will be enrolled in this long-term study. Participants will undergo yearly clinical exams including medical history, physical exams, blood tests, EKG, echocardiograms, and pulmonary function tests. Adult participants will also donate bone marrow initially, and some will undergo leukapheresis sessions where blood is processed and returned. Both affected and unaffected family members will provide blood and tissue samples for research to help identify genetic and immunologic factors involved in FE. Throughout the study, participants will be regularly evaluated to monitor the natural history of FE and to identify early signs of disease progression. Researchers will measure immunologic and molecular mechanisms, clinical markers, and any organ damage caused by eosinophilia. Medical care for any needed treatment will be provided by clinical services or local doctors. The study is indefinite in duration, with yearly assessments and additional tests as needed.
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