Perth

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.

This research aims to assess the drug XTMAB-16 in adults with pulmonary sarcoidosis, a condition involving lung inflammation. The study is a combined Phase 1b2 trial focusing on patients diagnosed at least six months prior, including those with or without additional organ involvement. It follows guidelines from leading respiratory societies and seeks to understand the drugs safety and effects while tapering corticosteroid use. Participants receive XTMAB-16 or a placebo through infusions at varying doses and schedules over two parts. In Part A, patients get doses every 2 or 4 weeks for 12 weeks, with four different dosing regimens including placebo. Part B continues treatment with the dose established in Part A for 24 weeks or placebo. Participants are asked to follow certain dietary restrictions and testing requirements during the study. Throughout the study, participants undergo monitoring for adverse events and steroid dose reductions, with evaluations lasting up to 34 weeks. Assessments include safety checks, lung function tests, and tracking corticosteroid use. The study measures include the rate of side effects, ability to reduce steroid doses, and maintenance of steroid reduction. Participants provide informed consent and receive ongoing support to comply with study procedures.

This research aims to improve diagnosis and prediction of outcomes in people at risk for or diagnosed with interstitial lung diseases ILD. It focuses on evaluating non-invasive tests based on blood and breath samples, especially among Pigeon Fanciers who have a higher risk of developing ILD due to their bird exposure. The study will also include patients diagnosed with ILD, including those with severe respiratory failure, to better understand how these tests relate to disease progression and patient experience. Participants will be grouped as active Pigeon Fanciers, ILD clinic patients, or hospital patients with ILD. Initial assessments for Pigeon Fanciers include collecting height, weight, lung function tests, medical history, and pigeon exposure details. Blood samples will be taken to measure antibodies and other biomarkers, and breath samples will be collected for analysis. Repeated assessments will be done over time to observe changes related to exposure or illness development. Participants will attend assessments at national pigeon meetings or clinical visits, where researchers will measure lung function, collect samples, and record symptoms and health changes. These data will help link test results to clinical outcomes over five years, including disease progression, treatment response, and survival. The study also evaluates how acceptable these tests are to participants, aiming to guide future clinical trials and improve ILD care.

Researchers are studying inhaled treprostinil to assess its safety and effectiveness in people with progressive pulmonary fibrosis PPF. This Phase 3, multinational, randomized, double-blind, placebo-controlled trial will compare inhaled treprostinil to a placebo over one year. The study focuses on adults diagnosed with PPF who have shown lung fibrosis progression despite standard treatments. Participants will be randomly assigned to receive either inhaled treprostinil or a matching placebo using an ultrasonic nebulizer four times a day. The dose starts at 3 breaths per session and will be gradually increased to a target of 12 breaths per session or the highest tolerated dose. The treatment period includes six visits at weeks 4, 8, 16, 28, 40, and 52. Those completing the 52-week treatment may join an open-label extension study. During the study, participants will undergo lung function tests like forced vital capacity FVC and lung diffusion capacity DLCO, complete questionnaires about their lung disease, and have blood tests to measure biomarkers. Researchers will monitor safety by tracking adverse events, vital signs, lab results, and electrocardiograms. The main measure is the change in lung function from the start to week 52, with additional assessments of clinical worsening, acute lung exacerbations, survival, and oxygen use.

Researchers are evaluating the effects of PIPE-791, an oral drug, in adults diagnosed with Idiopathic Pulmonary Fibrosis IPF. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, tolerability, and how the drug moves through the body in participants with IPF, whether or not they are on background treatment. Approximately 324 participants will join this global study to better understand how PIPE-791 may impact lung function in this condition. Participants are randomly assigned to one of three groups two different daily oral doses of PIPE-791 or a matching placebo. The treatment period lasts 26 weeks, during which participants take their assigned tablets daily. The entire study duration can extend up to 36 weeks, including time for screening before treatment begins and follow-up after treatment ends. During the study, participants undergo lung function tests, including measuring forced vital capacity FVC at baseline and various points up to Week 26 to assess changes. Researchers will also monitor safety and side effects through reported adverse events up to Week 30. Additional assessments include lung imaging with high-resolution CT scans and other lung function measures. Participants will be followed throughout the study with scheduled visits to collect data on how they respond to the treatments and any potential side effects.