Dagenham

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

Researchers are evaluating whether a new asthma inhaler using a climate-friendly propellant called HFA-152a works as well and is as safe as inhalers using the existing HFA-134a propellant. This study focuses on adults with mild to moderate asthma who have been diagnosed for at least six months. The trial is a Phase II, multinational, double-blind, randomized, active-controlled, three-way crossover study conducted across Europe, Latin America, Ukraine, South Africa, and the United Kingdom. It plans to enroll 468 participants. Participants will use one of three inhalers: CHF5993 pMDI with the new HFA-152a propellant, CHF5993 pMDI with the existing HFA-134a propellant, or CHF718 pMDI with HFA-134a. For each inhaler, the dosing is two puffs twice daily. The study will compare these inhalers in a randomized crossover design to evaluate therapeutic equivalence. The inhalers are administered as pressurized metered-dose inhalers (pMDI). During the study, researchers will assess lung function by measuring forced expiratory volume in 1 second (FEV1) at several time points, including changes from baseline after dosing on Day 1 and Day 28. Participants will be monitored for safety and effectiveness throughout the study, which includes multiple visits for lung function tests and asthma control assessments. The trial includes adherence monitoring through an e-Diary and treatment compliance checks.