Midland

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.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

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.

The trial investigates the safety and effects of MTX-463, an antibody targeting WISP1, in adults aged 40 or older with idiopathic pulmonary fibrosis IPF. This Phase 2a study compares MTX-463 to a placebo, allowing participants to continue approved IPF treatments like pirfenidone, nintedanib, or nerandomilast if stable. Participants must meet specific diagnostic criteria and lung function thresholds to join. Participants receive either MTX-463 or placebo through intravenous infusions every 4 weeks from Day 0 to Week 20. The treatment phase concludes with a visit at Week 24, followed by a safety follow-up at Week 28. Lung function tests including forced vital capacity FVC and lung fibrosis assessments are done at screening, baseline, and during treatment visits. Blood samples are collected regularly to monitor safety and drug levels. Throughout the study, participants attend visits every 4 weeks for assessments of lung function, safety labs, and WISP1 protein levels. The main outcome measures include changes in FVC after 24 weeks and safety profiles over 28 weeks. Participant involvement spans from screening through final safety follow-up, with careful monitoring to evaluate the study drugs impact and tolerability in IPF.