Bronchial cysts are rare cystic formations typically arising in the respiratory system and often evaluated through various clinical studies. Trials involving bronchial cysts explore intervention research to assess the safety and effectiveness of diff...
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Found 176 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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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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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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Researchers are investigating two different doses of inhaled Glycopyrronium GP delivered by metered-dose inhaler MDI as add-on treatments to Budesonide and Formoterol Fumarate BFF MDI in children aged 4 to less than 12 years with asthma. This Phase II, multi-center, randomized, double-blind, crossover study aims to assess how these doses affect lung function compared to a placebo MDI added to BFF MDI. The study is designed to better understand the potential benefits and safety of these treatments in this young population with asthma. Participants will undergo a 3-week run-in period followed by three 3-week treatment periods. During the treatment periods, each participant will receive three treatments in different sequences BFF MDI combined with GP MDI Dose A, BFF MDI combined with GP MDI Dose B, and BFF MDI combined with placebo MDI. GP MDI and BFF MDI are both administered twice daily by oral inhalation. The study concludes with a safety follow-up visit 12 to 16 days after the last dose. Throughout the study, lung function will be closely monitored, with the primary outcome being the change from baseline in forced expiratory volume in one second FEV1 at 1-hour post-dose at the end of each 3-week treatment period. Additional measures include morning pre-dose trough FEV1 changes. Participants will attend scheduled visits for assessments, including lung function tests and safety evaluations, ensuring detailed monitoring of treatment effects and participant well-being during the study period.
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Researchers are evaluating the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate, delivered via a multidose dry powder inhaler with an electronic module, in participants aged 12 years and older with asthma. This Phase 3 trial aims to compare this combination treatment to fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. The study also assesses different dosing schedules, safety, tolerability, and pharmacokinetics of these inhalers. Participants will be randomly assigned to one of four groups receiving either the combination inhaler, fluticasone propionate inhaler, albuterol sulfate inhaler, or placebo, all with integrated electronic modules. Treatments are administered over a 4-week period with dosing four times daily. Pharmacokinetic assessments will be conducted after a single dose administration. The study is double-blind and placebo-controlled, with a parallel group design. Throughout the approximately 10-week study period, including screening and treatment, participants will undergo evaluations including lung function tests measuring forced expiratory volume in one second FEV1, asthma control questionnaires, and safety assessments. Researchers will monitor treatment-emergent adverse events and measure blood concentrations of the inhaled drugs. The study includes electronic monitoring of inhaler use and collects data at baseline, during treatment, and at week 4, with follow-up to assess efficacy and safety.
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Researchers are evaluating the characteristics and outcomes of individuals with asthma across different levels of disease severity in routine clinical practice. The study aims to describe participants sociodemographic and clinical features, treatment patterns, disease burden, biomarkers, and both asthma-specific and general quality of life. This research includes both a cross-sectional analysis and a prospective follow-up to observe changes in disease progression over time. The study involves participants receiving standard asthma care, including treatment with varying doses of inhaled corticosteroids andor biologic therapies. Participants are grouped based on asthma control levels and biomarker status. The first part of the study collects baseline data cross-sectionally, while the second part follows participants prospectively to assess differences in asthma symptom control, treatment use, lung function, and comorbidities over a two-year period. Participants will be involved in scheduled data collection including patient and physician-reported outcomes, lung function tests, blood samples, and questionnaires assessing quality of life and symptom control. The study monitors treatment utilization and health resource use from the prior year and during follow-up visits at one and two years. The total participation period spans up to two years with ongoing assessment of disease characteristics and outcomes.
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Researchers are evaluating depemokimab as an additional treatment for adults and adolescents aged 12 and older with Type 2 asthma who are at risk of exacerbations. The study compares depemokimab combined with standard care against a placebo with standard care to assess its impact on reducing asthma flare-ups and improving lung function over time. This Phase 3b4 trial aims to provide insights into the safety and effectiveness of early intervention with depemokimab. Participants are randomly assigned to receive either depemokimab or a placebo alongside their usual asthma treatments. The study is double-blind and involves multiple centers, lasting up to 156 weeks 3 years. During this period, participants will continue their standard asthma care while receiving the study drug or placebo. The trial monitors the rate of asthma exacerbations and other clinical outcomes to determine the impact of depemokimab compared to placebo. Throughout the study, participants will attend scheduled visits for assessments including lung function tests, asthma control and quality of life questionnaires, and safety evaluations. Researchers will track the annual rate of asthma exacerbations as the main outcome and observe changes in clinical remission, lung function, and asthma symptoms over two years. Safety monitoring will continue during the trial to ensure participant well-being, with the total participation lasting up to three years.
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The trial investigates the effects of a combination treatment using Fluticasone Furoate FF, Umeclidinium UMEC, and Vilanterol VI on lung function compared to a combination of FF and VI alone. The study focuses on adolescents aged 12 to 17 years with asthma that is not adequately controlled despite stable maintenance therapy with inhaled corticosteroids and long-acting beta2-agonists. The research aims to assess efficacy, safety, tolerability, and pharmacokinetics over a 24-week period in this age group. Participants receive either the FFUMECVI combination or the FFVI combination, both administered via the ELLIPTA inhaler. The study is randomized, double-blind, and conducted in parallel groups. Treatments are given daily, and the trial lasts for 24 weeks to monitor the effects on lung function and asthma control. During the study, participants undergo lung function tests measuring forced expiratory volume in 1 second FEV1 at the start and after 24 weeks. Additional assessments include asthma control questionnaires at baseline and week 24 to evaluate changes in symptoms. Safety and tolerability are monitored throughout, with the total participation lasting 24 weeks.
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