Checiny

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 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 evaluating depemokimab for adults with uncontrolled Hypereosinophilic Syndrome (HES) who are already receiving standard care treatment. This Phase 3 study is a 52-week, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants must have a confirmed HES diagnosis, be on stable therapy for at least 4 weeks before randomization, have experienced at least two disease flares in the past year, and have a blood eosinophil count of at least 1,000 cells/µL during screening. Historical flares are defined by worsening symptoms or increased eosinophils that require treatment changes. Eligible participants will be randomly assigned in a 2:1 ratio to receive either depemokimab or a matching placebo, while continuing their usual HES therapy. The study medication will be administered alongside standard care to assess the drug’s effect on reducing HES flares over the course of one year. During the study, participants will be monitored regularly for flare frequency, safety, and treatment effects. Researchers will collect data on the number of HES flares up to 52 weeks. Safety assessments and clinical evaluations will be conducted throughout the study to understand how participants respond to the treatment and to monitor any adverse events.

Researchers are evaluating the efficacy, safety, and tolerability of adding subcutaneous lunsekimig compared with placebo as treatment for adults aged 18 to 80 with high-risk asthma who currently do not qualify for biologic therapies. This Phase 2, randomized, double-blind, placebo-controlled study focuses on participants with mild-to-moderate asthma diagnosed for over a year, who have had at least one asthma exacerbation in the previous year. The goal is to better understand lunsekimig's effects in this specific asthma population. Participants will be randomly assigned to receive either subcutaneous injections of lunsekimig or placebo over approximately 52 weeks. Alongside this, they may continue using other asthma medications such as various inhaled treatments including fluticasone/salmeterol, budesonide/formoterol, budesonide/albuterol, or short-acting beta agonists. The study includes up to 18 visits throughout the treatment period, with some participants possibly continuing into a long-term safety (LTS) study lasting up to 60 weeks total. During the study, participants will undergo regular assessments to monitor asthma control, lung function, and the rate of asthma exacerbations. The primary measurement is the annualized rate of asthma exacerbation events from baseline up to 52 weeks. Safety and tolerability will also be closely observed. The total study duration for most participants will be around 64 weeks if they do not enter the LTS study. Researchers will gather data through clinical visits, lung function tests, and ongoing safety monitoring to evaluate the treatment's impact and participant health throughout the trial.