Boerne

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating how the medications budesonide and formoterol, delivered through two different inhaler devices, move through the body in children with asthma aged 4 to less than 12 years. This phase I study aims to assess the pharmacokinetics and safety of these treatments to better understand their effects in this young population. Participants must have a clinician-diagnosed asthma for at least 3 months and be on stable asthma treatment prior to joining. The study uses a single-dose, two-period crossover design where participants are randomly assigned to receive either Symbicort Aerosphere or Symbicort pressurized metered dose inhaler (pMDI) first. Each participant will receive two treatments with a washout period of 28 to 42 days between doses. Both treatments involve two puffs of budesonide/formoterol fumarate delivered as oral inhalations, with one treatment serving as the test and the other as the reference formulation. Participants will have blood samples taken at various times up to 8 hours after dosing to measure medication levels in the blood. These include maximum plasma concentration and area under the concentration-time curve to assess drug absorption. Safety will be monitored throughout the study, including a negative pregnancy test for females who have reached menarche. The total study duration includes screening, two treatment periods, and safety follow-up.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

Researchers are evaluating the safety and effects of a study medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. This condition makes breathing difficult and affects quality of life. The study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to determine if PF-07275315 is safe and effective for this group. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections administered in the clinic over 12 weeks. The study compares these two groups to assess treatment responses. The trial includes a total of 9 clinic visits and lasts about 7.5 months for each participant. During the study, participants will undergo various assessments including lung function tests to measure forced expiratory volume in 1 second (FEV1), safety monitoring through adverse event tracking, laboratory tests, vital sign checks, and electrocardiograms. These evaluations occur from baseline through 24 weeks to observe changes and treatment tolerability.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the safety, tolerability, and activity of inhaled GDC-6988 in adults with muco-obstructive diseases, including Non-cystic Fibrosis Bronchiectasis and Chronic Obstructive Pulmonary Disease. This Phase 1c, open-label, multicenter study aims to understand how the treatment affects lung function and adverse events in these participants. The study involves administering GDC-6988 using a dry powder inhalation device. Participants must be on stable treatment for their condition and demonstrate proper use of the inhaler. The study includes different cohorts with specific criteria based on disease type and severity, such as chronic sputum production and lung function measures. Some participants will provide sputum and blood samples for exploratory biomarker research. Participants will be monitored for adverse events and lung function abnormalities using spirometry over a period of up to 6 weeks. Safety will be assessed using the Division of Acquired Immunodeficiency Syndrome Toxicity Grading Scale. The study also evaluates lung function changes and collects biomarker data to understand treatment effects. The total duration and follow-up details are aligned with these assessments to ensure participant safety and data collection completeness.

Researchers are evaluating the effectiveness and long-term safety of dupilumab treatment in children aged 2 to less than 6 years who have uncontrolled asthma or recurrent severe asthmatic wheeze. This Phase 3, two-arm study includes a randomized, double-blind, placebo-controlled design to compare dupilumab with placebo in this young population. The study aims to better understand how dupilumab may affect severe asthma flare-ups and monitor safety over an extended period. The study is divided into two parts. Part A lasts up to 68 weeks and includes a 4-week screening period, a 52-week treatment phase where participants receive either dupilumab or placebo by subcutaneous injection, and a 12-week follow-up after treatment ends. After Part A, eligible participants have the option to join Part B, an open-label extension lasting an additional 52 weeks of dupilumab treatment followed by another 12-week post-treatment follow-up. This structure allows researchers to assess both short-term and longer-term effects of dupilumab. Participants will attend clinic visits for assessments throughout the study, where researchers will monitor the number of severe asthma exacerbations during the first 52 weeks and track any adverse events from Week 52 to Week 116. Evaluations include safety checks, questionnaires, and other study procedures to understand treatment impact and tolerability. The total participation duration for each child can be up to 120 weeks, providing comprehensive data on dupilumab's use in young children with asthma or severe wheezing.