M5500grb

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 new diagnostic methods for asthma and chronic obstructive pulmonary disease COPD that can be used in primary care settings. Traditional spirometry relies on patients ability to perform forceful breathing maneuvers, which can be challenging and limit accurate diagnosis. This observational study aims to assess how well oscillometry and fractional exhaled nitric oxide FeNO testing work compared to specialist diagnosis, across six countries in the Middle East, Africa, Asia, and Latin America, to improve early and reliable detection of asthma and COPD. Primary care physicians will be trained to use oscillometry and FeNO testing following international guidelines and will use devices like the Ambulatory Lung Diagnosis System. Patients suspected of having asthma or COPD will be assessed through history, symptom questionnaires, and these tests. If specialist evaluation is not possible on the same day, it will occur within three days. No follow-up visits are planned. The study compares diagnosis accuracy and feasibility between primary care and specialist settings. Participants will provide consent and complete symptom questionnaires, followed by primary care assessments including oscillometry and FeNO testing. Researchers will measure the accuracy of primary care diagnoses against specialist diagnoses using statistical methods and observe agreement, sensitivity, and specificity within one to three days. The study does not require further follow-up, aiming to inform integration of these diagnostic tools into routine primary care for better asthma and COPD identification.