This trial is for patients with bronchiectasis who completed the Boehringer Ingelheim 1397-0012 Airleaf parent study. This is a continuation of the Airleaf study and is meant to assess the long-term safety, effectiveness, and tolerability of the study drug (BI 1291583). Approximately 220 patients will be enrolled into the study and will be randomized into either 1 milligram, 2.5 milligram, or 5 milligram study drug or placebo. Patients will be treated for approximately 1 year, while study staff monitor the number of patient pulmonary exacerbations.
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, efficacy and safety study of subjects with PPF (Progressive Pulmonary Fibrosis) treated with inhaled treprostinil over a 52-week period. This study is investigating whether a drug called inhaled treprostinil (brand name Tyvaso®) works to help people with PPF improve their lung function tests. The purpose of this research study is to see how well inhaled treprostinil works in participants with PPF and to gather information on how safe it is. This study will look at changes in your breathing tests, also called lung function tests. About 698 people will participate in this study from about 150 medical centers. Your participation in this study is voluntary and will last approximately 58 weeks. This time includes a Screening Period that could last up to approximately 6 weeks plus a 52-week Treatment Period.
The study seeks to evaluate the effectiveness of ARINA-1, an investigational inhaled medication, in reducing cough and mucus production in patients who are diagnosed with chronic bronchitis. If enrolled in this study, there will be four clinic visits, one telehealth visit, and one phone call. As part of the study assessments, a cough monitor will be worn on the wrist, as well as repeat spirometry, questionnaires, and bloodwork will be completed. The ARINA-1 will administered with a nebulizer provided to participants and is taken twice daily for 28 days. The total duration of this study is up to 12 weeks for each enrolled participant.
Compensation will be provided for your time for each visit that is completed.