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Showing 1-20 of 1,996 trials
NCT06427876
The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra). 1. Development of unexpected related AEs\* 2. To grasp development of related AEs\* in the real-world post-marketing setting. 3. Effectiveness (pulmonary function and asthma control) \* AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug
NCT06052267
The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). Secondary Objectives: To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria
NCT07301736
This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.
NCT05254314
This is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma despite the use of inhaled steroids and with excess body weight. This study will test the central hypothesis that semaglutide will improve asthma control and reduce airway inflammation due to direct effects on the respiratory tract in adult asthma associated with obesity.
NCT01224691
Background: * Human respiratory syncytial virus (RSV) is a virus that causes respiratory tract infections, and is frequently responsible for hospital visits in infants and children. It can also trigger severe breathing problems for individuals who have asthma, but these infections are generally better tolerated in non-asthmatics. Some research suggests that lack of an efficient immune system response in people with asthma may make it difficult for the body to fight the effects of RSV. * Transforming Growth Factor-beta (TGF-\[beta\]) is a chemical in the body that is more prevalent in the lungs of people with asthma and related respiratory disorders. More information is needed about the effects of TGF-\[beta\] and whether it makes individuals with asthma more prone to developing RSV. Researchers hope to use this information to determine possible treatments and therapies for individuals with asthma who contract RSV. Objectives: \- To determine the possible role of TGF-\[beta\] in increased asthmatic susceptibility to RSV infection. Eligibility: \- Individuals between 18 and 60 years of age who are either healthy nonsmokers or mild asthmatics. Design: * This study involves a screening visit and a study visit. * Participants will be screened with a medical history and physical examination, as well as blood samples and a pulmonary function test. * At the study visit, participants will receive mild anesthetic and have a bronchoscopy, in which researchers insert a bronchoscope through the participant s nose or mouth and into the lungs to examine the lungs and collect lung cells. * Participants will be contacted by a research team member 24 36 hours after the bronchoscopy to ask about any side effects from the procedure.
NCT07666490
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with a BDP/FF/GB 100/6/12.5 µg on asthma control outcomes relative to ICS/LABA therapy with BDP/FF 200/6 μg in a population with asthma poorly controlled.
NCT06732141
This study, the Remote Anxiety Management for ICS-resistant Asthma Study (RAMICS), explores strategies to improve medication adherence and anxiety management in asthma patients who are resistant to using inhaled corticosteroids (ICS) due to anxiety. Asthma is a chronic respiratory disease affecting millions worldwide, and ICS therapy is essential for controlling symptoms and preventing severe exacerbations. However, many patients struggle with adherence, especially those with anxiety about ICS side effects. RAMICS is a multicenter, open-label, randomized controlled trial designed to evaluate the effectiveness of personalized telephone-based interventions, including medication education, progressive muscle relaxation (PMR), motivational interviewing (MI), and lung rehabilitation guidance. The study will enroll 216 adult asthma patients with poor ICS adherence and clinically significant anxiety. Participants will be randomized into two groups: the intervention group, receiving weekly telephone sessions, and the control group, receiving standard follow-up calls. The study aims to assess improvements in ICS adherence, reductions in anxiety and depression, better asthma symptom control, and enhanced quality of life. Outcomes will be evaluated immediately after the 8-week intervention and during a 3-month follow-up. By addressing both psychological and medication adherence challenges, this research aims to provide practical solutions for improving asthma management.
NCT07642388
The main goal of this study is to evaluate the effectiveness of adaptive sequential implementation strategies based on facilitation in promoting the sustainable and widespread adoption and scaling up of the Integrated Care Pathway for Acute Asthma - ASMAbat across all Primary Care and Hospital Pediatric Services of Osakidetza - Basque Health Service.
NCT07643753
What is this study about? The investigators want to see if exercise and education sessions can help children and young people (aged 10-17) with asthma, manage the participants asthma better. The investigators will place participants that are recruited to this study into one of three groups by a computer (randomly): Group 1: Usual Care: Continue with normal asthma treatment. Group 2: Education: Usual care + a 45-minute online asthma education class once a week. Group 3: Exercise \& Education: Usual care + 3 exercise sessions a week and asthma education classes.
NCT03937804
Background: Some groups of people have a high prevalence of asthma and allergic disease. Also, asthma and allergic disease are often found in several members of the same family. Researchers want to learn more about what factors might cause asthma, both genetic and environmental. Objective: To build a collection of information to try to find genes that cause conditions and disorders such as asthma and allergic disease. Eligibility: People ages 18 99 of self-identified African, African American, or African Caribbean descent who either have no history of asthma or wheeze or have a physician s diagnosis of asthma Design: Participants will be screened with an interview by phone or in person. Participants will fill out a questionnaire about their general health and exposure to allergens and smoke. Participants will have a physical exam. Participants will have blood tests. Participants will provide a skin cell sample. Up to two samples will be taken from the inside of the nose. A brush will be used to take the samples. Participants will have a breathing test. They will be asked to blow forcefully 3 or more times into a lung function machine. Participants may have their blood and skin samples sent to a lab. DNA will be extracted from the samples and tested. Participants blood and skin samples will be stored. Samples may be used in future research studies.
NCT07637292
The main objective of asthma pharmacological management in adults and teenagers is to maintain long-term control of the disease, including symptom relief, the prevention of exacerbations, the improvement of pulmonary function, the reduction of limitations in daily life and side effects of pharmacological treatments. Dupilumab is a recombinant human monoclonal antibody that inhibits signalling of both IL-4 and IL-13, two Type 2 cytokines involved in inflammatory pathway. Dupixent obtained a European Marketing Authorization in September 2017 and was reimbursed in France from March 5, 2019 in adults with moderate-to-severe atopic dermatitis. On November 10, 2020, the reimbursement of Dupixent was extended to adults and adolescents aged 12 and over as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils (≥ 0.150 g/L) and/or raised fraction of exhaled nitric oxide (FeNO ≥ 20 ppb), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Lastly, on July 22, 2021, Dupixent was also reimbursed in patients with severe nasal polyposis. Primary objective: To describe the characteristics of patients using dupilumab for severe asthma in a real-world setting. Secondary objectives: * To describe the Health Care Resource Use (HCRU) and associated costs of severe asthmatic patients using dupilumab. * To describe the use of corticosteroids (oral and inhaled) before and after dupilumab initiation. * To study persistence with dupilumab in real-world
NCT06461403
This will be a randomized, controlled, clinical trial. The investigators aim to determine the feasibility of and efficacy of the Inhaler Trainer Device for ongoing inhaler skill training. The research team will enroll 140 patients from the inpatient or outpatient setting from the University of Chicago Medicine over the course of up to 12 months. Participants will complete assessments, a lung function test via spirometry, and inhaler education via either the Inhaler Trainer Device learning program or Brief Intervention. All participants will return at 6 weeks (window of +/- one week) post-initial inhaler education for an in-person evaluation of their inhaler skills, lung function, and acute care utilization. Finally, a post-study semi-structured interview will be conducted to gather feedback on the device after the 6-week visit has been completed.
NCT06457009
Study Participants: Suspected asthma population, defined as individuals whose score of asthma screening questionnaire used in ECRHS study exceeds 0 and whose age is 35 and above. Intervention: Within the intervention arm, we have constructed a population-based pay-for-performance mechanism to encourage medical practitioners to care for population health. For study participants in the intervention arm, we will ask them to finish an online ECRHS questionnaire with notification of his or her suspected asthma status. Individuals whose score of ECRHS asthma screening exceeds 0 will be given a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For suspected asthma population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose FEV1 improved by ≥12% and ≥200 mL following bronchodilator administration with 400 ug salbutamol, they will be spirometry-defined undiagnosed asthma patient and will be encouraged to seek treatment and medication to the superior hospitals. Additionally, we provide (1) two digital health intervention programs to smokers and individuals with mental health issues; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program in China for those with abnormal blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12. Comparison: Those who are assigned in the control arm, we will ask them to finish the same ECRHS online questionnaire with notification of his or her suspected asthma status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given. Outcomes: The primary outcomes are asthma knowledge, lung function testing, and ACT score at month 12.
NCT07613671
Asthma is a chronic inflammatory disease of the airways that results in tissue remodeling, airflow limitation, and bronchial hyperresponsiveness. This study aims to evaluate the long-term effects of photobiomodulation using an LED vest in the management of pediatric asthma. It is a randomized clinical trial involving children aged 6 to 17 years diagnosed with mild to moderate asthma, divided into two groups: an intervention group (using a vest with active LEDs) and a control group (using the vest turned off, simulating the intervention without light emission). The methodology includes clinical and functional assessments such as spirometry, the Asthma Control Test (ACT), the GINA questionnaire, and the Incremental Step Test (IST), which measures exercise tolerance. Photobiomodulation through LEDs promotes cellular biostimulation without thermal effects, modulating inflammatory processes and optimizing tissue regeneration. It is expected that the LED vest will contribute to improving pulmonary function, enhancing quality of life, and complementing conventional treatments. This project aims to advance the clinical application of photobiomodulation as an accessible and effective therapeutic alternative for pediatric asthma.
NCT06932263
This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.
NCT07245576
Current diagnostic methods for asthma and chronic obstructive pulmonary disease mostly depend on pulmonary function tests, especially spirometry. While spirometry is a foundational tool, its diagnostic accuracy is often limited by the patient's ability to perform forceful breathing maneuvers, as well as technical and reproducibility challenges, and the need for proper equipment and training. These constraints can compromise effective diagnosis of asthma and COPD in primary care settings. Prompt and accurate diagnosis by primary care physicians is essential for better patient outcomes. Although variable airflow limitation often measured as a change in FEV1 after bronchodilator is a hallmark of asthma, inconsistencies in test quality and reversibility criteria create challenges in distinguishing asthma from COPD. These complexities highlight the need for alternative diagnostic tools beyond traditional spirometry. This observational study is designed to evaluate the diagnostic accuracy and technical feasibility of using oscillometry and FeNO testing in primary care for suspected asthma and COPD, compared to conventional specialist-based diagnostics. The study will be conducted across 6 countries in the MEA, Asia, and Latin America, with two hospital sites per country. Primary care physicians will be trained in oscillometry and FeNO testing using standardized protocols and tools such as the Ambulatory Lung Diagnosis System following GINA and GOLD guidelines. Eligible patients will provide consent, complete a history and symptom questionnaire, and undergo primary care-based assessment for a provisional diagnosis. If specialist assessment cannot occur the same day, it will be done within three days. No follow-up visits are planned. Study outcomes will inform the feasibility and accuracy of integrating these methods into routine care, aiming to improve the early and reliable diagnosis of asthma and COPD.
NCT07160868
The OSADA (Obstructive Sleep Apnoea in Difficult Asthma) trial is an open-label, randomized control trial investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on a asthma control in patients with difficult-to-control asthma. Participants will undergo home-based sleep studies to assess for OSA and are then allocated to one of three arms: 1) Patients with OSA treated with CPAP (intervention group), 2) Patients with OSA not treated for OSA (control group) and 3) Patients without OSA (reference group). The primary objective is to evaluate whether treating OSA improves asthma control, symptom burden, and quality of life compared to untreated OSA and to patients without OSA. Secondary outcomes include exacerbation rates, sleep quality, and healthcare utilization. This trial aims to clarify the contribution of OSA to poor asthma control and the potential benefits of integrated sleep and respiratory care in this complex population.
NCT06748053
This study is trying to find the right dose of a long-lasting medicine called GSK5784283 for people with asthma that remains uncontrolled even though they are using regular asthma treatments. GSK5784283 blocks the action of an inflammatory protein called TSLP that may be contributing to your asthma. The study will be conducted in two parts - Part A (dose finding phase) and Part B (extended dosing phase). Part A will assess the lung function, asthma control, participant safety and certain markers of asthma inflammation in the air you breath out and in your blood. Part B will assess the safety and long-term effects of the repeated or single doses of GSK5784283.
NCT06513832
The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are: * To identify the factors related to differential experiences of asthma self-management * To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.
NCT07589439
What is the goal of this study? The goal of this clinical trial is to find out whether the study drug LQ036 (a nebulized solution taken by inhaling through a nebulizer) works to improve lung function and asthma control in people whose asthma is not well controlled. The study will also learn about the safety of LQ036, how the body processes it, and whether the body develops an immune response to it. What are the main questions? The most important question is: • Does LQ036 improve lung function (measured by FEV₁ - the amount of air you can blow out in one second) more than a placebo at Week 12? Other important questions include: * Does LQ036 improve lung function at other time points (weeks 1, 2, 4, 8, 16, 20, 24)? * Does LQ036 reduce asthma attacks (sudden worsening of asthma that needs extra treatment)? * Does LQ036 help people use less rescue medication (inhaler for quick relief) and have more days without asthma symptoms? * Does LQ036 improve scores on asthma control and quality of life questionnaires? * What medical problems do participants have when taking LQ036?