Perth

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating XTMAB-16 in a phase 1b/2 study involving patients with pulmonary sarcoidosis, a condition affecting the lungs and sometimes other parts of the body. This study aims to assess the safety and effects of multiple doses of XTMAB-16 compared to a placebo in patients with this condition, including those with or without extrapulmonary manifestations. The trial follows guidelines for diagnosing pulmonary sarcoidosis and requires participants to have a certain level of breathing difficulty and ongoing treatment with corticosteroids or other specified immunosuppressive medications. Participants receive infusions of either XTMAB-16 or a placebo. The study includes a multiple ascending dose phase and proof of concept evaluation. During the screening and treatment periods, participants must avoid grapefruit products and undergo tests to confirm they do not have COVID-19. Background therapies are maintained stable when possible, and corticosteroid tapering is managed under investigator supervision. The total study duration for the primary outcome assessment is 20 weeks in part A. Throughout the study, participants undergo regular assessments including monitoring for adverse events, laboratory tests, physical exams, and vital signs. The primary outcome measured is the rate of adverse events, including serious and dose-limiting toxicities and events of special interest. Safety monitoring is continuous, and participants must provide informed consent and be able to comply with study requirements. The trial excludes individuals with certain health conditions, recent treatments, or infections to ensure safety and accurate evaluation of the study drug.

Researchers are evaluating the safety and effectiveness of inhaled treprostinil in adults with progressive pulmonary fibrosis (PPF) over a period of 52 weeks. This Phase 3, multinational, randomized, double-blind, placebo-controlled study focuses on adults aged 18 and older who have PPF other than idiopathic pulmonary fibrosis (IPF) confirmed by lung imaging. Participants must show evidence of disease progression despite standard treatment for interstitial lung disease (ILD). Participants will be randomly assigned to receive either inhaled treprostinil or a placebo. Both are administered using an ultrasonic nebulizer delivering doses four times daily, starting at 3 breaths per dose and titrated up to a target of 12 breaths per dose as tolerated. The study includes six clinic visits during the treatment period at Weeks 4, 8, 16, 28, 40, and 52. After completing the 52-week visit, participants may have the option to join an open-label extension study. During the study, researchers will assess lung function through spirometry, measuring forced vital capacity (FVC), and monitor clinical worsening, acute exacerbations, survival, respiratory symptoms, and quality of life using questionnaires. Blood tests will measure biomarkers like NT-proBNP, and oxygen use and lung diffusion capacity will be tracked. Safety evaluations include monitoring adverse events, vital signs, lab tests, and heart function via ECG. The main outcome measured is the change in absolute FVC from baseline to Week 52.