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Found 2 Actively Recruiting clinical trials
Actively Recruiting
This research aims to assess the long-term safety and explore the effects of astegolimab in adults with chronic obstructive pulmonary disease COPD who have completed a 52-week treatment period in earlier studies named GB43311 or GB44332. The study is an open-label extension phase III trial sponsored by Hoffmann-La Roche, focusing on participants aged 40 to 90 years. Participants who qualify from the parent studies will receive astegolimab through subcutaneous injections every two weeks throughout the study duration. This open-label extension allows all participants to receive the active drug without placebo comparison. During the study, researchers will monitor participants for any adverse events up to 12 weeks after the last dose, focusing on the safety of astegolimab. Participants will be regularly assessed to track any side effects and overall health changes related to their COPD condition while on this treatment. The study began in June 2023 and will continue until July 2034, allowing for long-term observation.
Actively Recruiting
This trial investigates the efficacy and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma. These participants are already treated with a medium-dose inhaled corticosteroid and long-acting beta2-agonist ICS-LABA. The study compares adding benralizumab to increasing the inhaled therapy to a higher dose ICS-LABA. The research is a randomized, double-blind, active-controlled phase 3b trial designed to evaluate these treatments in people with a history of eosinophilic asthma who remain uncontrolled on medium-dose ICS-LABA with or without other controllers except oral corticosteroids. Participants are randomly assigned to one of two groups one receives benralizumab 30 mg by subcutaneous injection along with medium-dose ICS-LABA, and the other receives a placebo injection plus high-dose ICS-LABA. Doses of benralizumab or placebo are given every 4 weeks for the first three doses, then every 8 weeks, with up to seven injections during the study. The study treatment schedules continue for 48 weeks. During the study, participants will undergo assessments including lung function tests, asthma control questionnaires, and quality of life surveys. Researchers will track the annual rate of asthma exacerbations, time to first exacerbation, and safety events throughout the 48-week period. Compliance with asthma controller medication is monitored via daily diaries. This comprehensive evaluation helps understand the impact of adding benralizumab compared to increasing inhaled therapy dose in uncontrolled eosinophilic asthma.