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Found 4 Actively Recruiting clinical trials

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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.

Age: 40Years - 80YearsAll GendersPhase 3
921 locations
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Actively Recruiting

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

Age: 18Years - 65YearsAll GendersPhase 3
256 locations
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Actively Recruiting

This research aims to evaluate participant satisfaction with subcutaneous ocrelizumab treatment in people with Multiple Sclerosis MS over a 12-month period. It will also investigate changes in neurofilament light chain NfL protein levels, a marker related to MS disease activity, and explore correlations between NfL levels and various clinical and imaging factors. The study is observational and follows participants who are starting ocrelizumab SC as part of their routine MS care. Participants will receive ocrelizumab as a subcutaneous injection according to their physicians discretion and local clinical practice. The study observes participants for up to 12 months to assess treatment satisfaction using the Therapy Administration Satisfaction Questionnaire for Subcutaneous administration TASQ-SC and other satisfaction questionnaires. Blood samples will be collected at baseline, month 6, and month 12 to measure NfL protein levels and other biomarkers. The study also monitors MS relapses, disability scores, and adverse events during this period. Throughout the 12 months, participants will undergo assessments of treatment satisfaction at multiple time points, including after the first injection, 6 months, and 12 months. Clinical evaluations, questionnaires, and blood tests will be conducted to track disease activity and participant experience. Researchers will measure satisfaction levels, changes in NfL concentrations, relapse rates, disability progression, and safety events. The study is designed to provide real-world data on patient experience and biomarker changes with subcutaneous ocrelizumab treatment in MS.

Age: 18Years +All Genders
92 locations
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Actively Recruiting

This research aims to compare two asthma inhalers that use different propellants in people with mild to moderate asthma. The study evaluates whether an investigational inhaler with a new climate-friendly propellant, HFA-152a, works as safely and effectively as inhalers using the existing HFA-134a propellant. This global Phase II study plans to enroll 468 patients in Europe, Latin America, Ukraine, South Africa, and the United Kingdom. Participants will use one of three inhaler treatments in a randomized, double-blind crossover design the investigational CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a, or CHF718 pMDI with HFA-134a. Each inhaler is taken as two puffs twice daily. The study compares lung function effects of these inhalers during treatment periods. During the trial, participants will be assessed for lung function through measurements like forced expiratory volume in 1 second FEV1 at baseline and after treatment. Researchers will monitor safety, treatment adherence, and asthma control over the study period. Participants undergo scheduled visits for these evaluations, with the study expected to complete in June 2027.

Age: 18Years - 75YearsAll GendersPhase 2
167 locations