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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.
Actively Recruiting
Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in bronchiectasis patients who are chronically colonized with Pseudomonas aeruginosa PsA. This Phase IIb study compares two dosage regimens of AZD0292 administered intravenously with placebo in participants aged 12 years and older. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent pulmonary exacerbations due to chronic PsA colonization, which negatively affects lung function, quality of life, and survival. Additionally, patients with cystic fibrosis bronchiectasis colonized with PsA are included as an exploratory group. Participants will receive either high-dose or low-dose AZD0292 starting on Day 1 via IV infusion, or placebo administered similarly. Subsequent doses will follow a schedule of assessments. This randomized, double-blind, placebo-controlled, parallel study aims to assess the efficacy, safety, and pharmacokinetics of AZD0292 over a variable follow-up period ranging from a minimum of 28 weeks up to 52 weeks. The trial also includes monitoring for adverse events and immune responses to the treatment. During the study, participants will undergo evaluations including lung function tests, quality of life questionnaires, and monitoring of exacerbation rates. Blood samples will be collected to measure drug concentration and antibody development. Safety assessments will continue through the treatment period and for up to 24 weeks after the last dose. The primary outcome is the annualized rate of exacerbations over the follow-up time, and secondary measures include severe exacerbation rates, time to first exacerbation, and changes in quality of life scores. Total participation spans from screening through the treatment and follow-up phases.
Actively Recruiting
This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.
Actively Recruiting
Researchers are evaluating the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease COPD who are receiving inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 40 to 80 years who have experienced multiple COPD exacerbations in the year prior to enrollment. The trial aims to assess tezepelumabs impact compared to placebo on COPD exacerbations and lung function. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. Treatment duration ranges from a minimum of 52 weeks to a maximum of 76 weeks. Following the treatment period, participants will undergo a 12-week off-treatment safety follow-up to monitor any lasting effects. Throughout the study, participants will be regularly assessed for COPD exacerbations, lung function changes measured by forced expiratory volume FEV1, and quality of life using questionnaires such as the St. Georges Respiratory Questionnaire and COPD Assessment Test. Blood samples will be collected to measure drug levels and immune responses. Safety and efficacy will be closely monitored, with total participation lasting up to approximately 88 weeks including follow-up.
Actively Recruiting
Atrial fibrillation AF is a major cause of heart-related illness and death, especially among Asian patients who face higher risks of serious bleeding such as brain hemorrhage compared to non-Asians. This research, called the COhort of antithrOmbotic use and cLinical outcomes in patients with Atrial Fibrillation COOL-AF Phase 2, aims to study how antithrombotic medication use changes over time and how these changes affect health outcomes in people with AF. The study is observational and conducted across multiple centers in Thailand. Participants in this study have known or newly diagnosed non-valvular AF and are followed without any intervention or treatment assigned by the study. The study plans to enroll about 3680 patients over two years from 33 centers. Participants will be monitored every 6 months for up to 3 years to observe patterns of medication use, particularly warfarin and non-vitamin K antagonist oral anticoagulants NOACs, and clinical events including stroke, systemic embolism, bleeding, heart attacks, and heart failure. Throughout the study, patients will have regular check-ins every six months to track their medication usage and health status. Researchers will collect data on important outcomes such as rates of stroke, bleeding events, and quality of life. The studys primary focus is on long-term safety and effectiveness of antithrombotic treatments in this population. The total participation duration can be up to 3 years, ensuring thorough observation of clinical outcomes and treatment patterns.
Actively Recruiting
Researchers are evaluating the best dose of dolutegravir DTG for treating people co-infected with HIV and tuberculosis TB who are also receiving rifampin RIF based TB therapy. This Stage II trial aims to understand how DTG behaves in the body when combined with RIF and to compare two dosing schedules of DTG in Thai patients newly diagnosed with pulmonary, pleural, or lymph node TB confirmed to be sensitive to RIF. The study will provide important information before moving on to a larger Stage III trial focused on safety and effectiveness.
Actively Recruiting
Researchers are evaluating the real-world effectiveness and safety of Nebilet4 nebivolol in adults with hypertension across seven Asian countries. This multinational, multicenter, observational, and prospective study aims to assess blood pressure changes, treatment adherence, quality of life, prescription patterns, and cardiovascular outcomes over up to three years. The study also compares Nebilet4 used alone versus in combination therapy and investigates the relationship between home and office blood pressure measurements. Participants include about 5,000 adults newly diagnosed with or having uncontrolled hypertension who have recently started Nebilet4 or been on it no more than two weeks. Patients are followed regularly for 12, 24, and 36 months, with blood pressure measured at each visit and home readings encouraged. The study collects data on medication dosing and frequency, adherence, and cardiovascular risk factors, while monitoring major adverse cardiac events such as heart attack, stroke, and cardiovascular death. During the study, participants complete questionnaires to assess quality of life and medication adherence every few months. Data are recorded through an electronic system ensuring consistency across sites. Researchers evaluate changes in systolic and diastolic blood pressure and the proportion achieving target blood pressure goals. Safety and any adverse events are documented, with follow-up visits extending up to three years to provide insights into the long-term management of hypertension with Nebilet4.
Actively Recruiting
Chronic Obstructive Pulmonary Disease COPD is a major global health issue, leading to high morbidity and mortality, especially in low- and middle-income countries. Frequent exacerbations worsen the disease and increase death risk. Current guidelines recommend triple inhaled therapy combining an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-agonist for patients with persistent symptoms. BreztriTrixeo BGF is one such therapy approved based on controlled clinical trials, but real-world data on its effectiveness and patient experience is needed. This observational study, called iCHOROS, will follow adults with moderate to severe COPD treated with BGF in routine clinical settings across Latin America, Asia, and the Middle East & Africa. Participants will be observed for 12 months after starting BGF, with assessments at baseline, 12, 26, and 52 weeks. The study collects clinical data and patient-reported outcomes without altering the standard care or providing study medication, focusing on real-life use and effects of BGF. Participants will have their COPD status, symptom scores, lung function, exacerbation history, and treatment satisfaction recorded during scheduled visits. The main measure is the change in COPD Assessment Test CAT score after 12 weeks. Additional measures include exacerbation rates, dyspnea severity, spirometry, and patient satisfaction with inhalers. The study aims to provide insights into BGFs impact in diverse populations over one year of follow-up.