The Program will allow access to brensocatib for patients who have completed the INS1007-301 ASPEN Clinical Trial. Patients will receive brensocatib 10 mg orally once daily. Eligible, compliant patients may receive brensocatib in this program until the drug is commercially available or until Insmed terminates the program.
This research seeks to gather important insights about patients' experiences of NCFBE-related exacerbations and brensocatib treatment by conducting semi-structured qualitative interviews in the USA. A total of up to 30 interviews of approximately one hour are planned. Patient must be at least 18 years old and currently participating in the brensocatib PTA program for at least 3 months.
This study is to evaluate an investigational study drug, itepekimab, for the treatment of bronchiectasis. The main purpose for this study is to assess the safety, efficacy, and tolerability of itepekimab in bronchiectasis in addition to the current background treatment you are receiving which may include bronchodilators, inhaled corticosteroids, mucolytics, and/or maintenance antibiotics. You will receive either the study drug or a placebo if you participate in this research. This study will include about 300 participants with bronchiectasis across approximately 20 countries worldwide.
This trial is a study to evaluate the efficacy and safety of ensifentrine inhalation suspension administered via nebulization (3 mg BID) compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFBE). Approximately 180 eligible subjects meeting all inclusion and no exclusion criteria will participate at approximately 45 sites in North America, the United Kingdom, and the European Union. Only subjects completing the Screening Period, meeting all inclusion, meeting no exclusion criteria, and meeting none of the randomization exclusion criteria will be randomized to receive blinded study medication: ensifentrine or placebo. The study has 3 periods: a Screening Period (up to 4 weeks, or 28 days), a Study Treatment Period (24 weeks or longer), and a Follow-up Period (4 to 10 days after your last dose of the study drug).
Subjects prescribed with the LibAirty system will be instructed to perform daily therapy sessions per standard device use recommendations. During the study period, subjects will be followed according to standard of care procedures and timelines for Bronchiectasis management. Clinical outcomes and healthcare resource utilization during the study period will be collected and compared to the 12-month period prior to study enrollment. Adherence to therapy will be evaluated by device recorded logs. Health related quality of life and subject satisfaction with the system will be evaluated by designated questionnaires, collected during clinic visits. Subjects will be followed for 12 months after starting therapy. Each subject will be required to complete a screening and enrollment visit, and any scheduled follow up visits according to standard of care timelines through 12 months (with data expected to be collected at 6 and 12 (±1m) months at minimum). Up to one hundred (100) subjects older than 21 years of age, with bronchiectasis who meet the entry criteria will be enrolled to the study, in up to ten (10) sites.