Rincon

Researchers are evaluating the safety and effectiveness of fixed dose combinations of ensifentrine with two different doses of glycopyrrolate compared to placebo and each drug alone in adults with chronic obstructive pulmonary disease (COPD). This phase IIb study focuses on measuring lung function improvements using bronchodilator effects in people with COPD. Participants have a history of smoking and meet specific lung function criteria to be included. Participants will be randomly assigned to one of six groups: two combination treatments of ensifentrine (3 mg) with glycopyrrolate at either 21.25 or 42.5 mcg, each drug alone as monotherapy, or placebo. All treatments are given twice daily for 28 days using a standard jet nebulizer. The study includes 1 to 2 weeks of screening, 4 weeks of treatment, followed by 1 week of follow-up. During the study, participants will undergo lung function testing at baseline and on days 1, 14, 28, and 29 to measure changes in forced expiratory volume in one second (FEV1). They will also have chest X-rays or CT scans reviewed, complete questionnaires on breathlessness, and have regular assessments to monitor safety and treatment effects. Participants must be able to use the nebulizer properly and attend all study visits over approximately 7 weeks.

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.

Researchers are studying AZD0292, a bispecific antibody, to see if it can prevent flare-ups in people aged 12 and older who have bronchiectasis with chronic colonization by Pseudomonas aeruginosa (PsA). This Phase IIb trial compares two different doses of AZD0292 given through intravenous infusion against a placebo. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent PsA-related lung exacerbations, which can worsen lung function, quality of life, and survival. Cystic fibrosis bronchiectasis patients colonized with PsA are also included as an exploratory group. Participants will receive either a high or low dose of AZD0292 or a placebo starting on Day 1 by IV infusion, with additional doses given according to the study schedule. The trial is randomized, double-blind, placebo-controlled, and parallel in design. Treatment effects, safety, and how the body processes the drug will be studied over the course of dosing. During the study, participants will be monitored for lung exacerbations over a follow-up period ranging from 28 to 52 weeks. Researchers will assess lung function, collect airway samples to confirm PsA colonization, and track any side effects or adverse events. The main measure of success is the annualized rate of exacerbations. Participants must adhere to study visits and assessments throughout the trial to help determine the drug’s effectiveness and safety.

Researchers are investigating the potential benefits of GB-0895 as an additional treatment for adolescents and adults with severe asthma that remains uncontrolled despite using inhaled corticosteroids and other usual asthma treatments. This global, multicenter Phase 3 trial compares the effects of GB-0895 to a placebo in patients aged 12 to 80 years with severe uncontrolled asthma. The study also includes an optional open-label extension phase to further assess long-term effects and safety. Participants are randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every 6 months over a 52-week treatment period. Before treatment, there is a screening and run-in phase lasting about 6 weeks. After the 52 weeks of treatment, participants enter a follow-up period lasting up to 38 weeks or may choose to join the optional open-label extension lasting up to 90 weeks, during which they continue receiving GB-0895 at specified intervals. Throughout the study, participants attend visits every 1 to 2 months after the first month to monitor their health and asthma control. Researchers evaluate the annualized asthma exacerbation rate as the main outcome. Safety assessments include physical exams, vital signs, lab tests, and careful monitoring for adverse effects. The study aims to enroll about 786 participants globally to thoroughly assess the safety and effectiveness of GB-0895 as an add-on therapy for severe uncontrolled asthma.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will 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 up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating the effects and safety of the study medicine PF-07275315 for treating moderate to severe chronic obstructive pulmonary disease (COPD), a condition that makes breathing difficult and lowers quality of life. This clinical trial includes adults aged 35 to 80 years who have had COPD for at least 12 months and a history of at least two moderate or severe COPD flare-ups in the past year. The study has two phases: Phase 2 and Phase 3, each designed to assess different outcomes related to lung function and lung flare-ups over time. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections (shots under the skin) at the clinic. The Phase 2 part lasts 24 weeks with 11 clinic visits and focuses on the change in lung function measured by forced expiratory volume in 1 second (FEV1). The Phase 3 part lasts 52 weeks with 18 clinic visits and evaluates the annual rate of moderate or severe COPD flare-ups. Both study phases compare the effects of PF-07275315 to the placebo to assess safety and effectiveness. During the study, participants will visit the clinic regularly for assessments including lung function tests and health evaluations. They will continue their usual COPD maintenance treatments throughout the trial. Researchers will monitor lung function changes and the frequency of COPD exacerbations as primary outcome measures. Participants remain in the study for about 40 weeks in Phase 2 or about 68 weeks in Phase 3, including follow-up visits to ensure safety and collect health information.