The purpose of this study is to evaluate the efficacy, safety, and tolerability of the study drug, brensocatib, as treatment for NCFBE. This is a double-blinded study.
The maximum study duration is 62 weeks total for an individual participant, including a Screening Period of up to 6 weeks, a Treatment Period of 52 weeks, and an End-of-Study Visit 4 weeks following the end of treatment. Approximately 1,620 subjects between the ages of 18 and 85 years, with diagnosed NCFBE are expected to participate in this study. The study is being conducted at approximately 480 centers in North America, Europe, Japan, and the rest of the world. All subjects will complete the same study procedures. The study will last approximately 62 weeks from the Screening (Visit 1) to the End of Study (Visit 12). There will be 12 visits including the Screening Visit (1 visit), Study Treatment Visits (10 visits: 6 visits are in the study clinic [Visits 2, 3, 5, 7, 9, and 11], and 4 visits by telephone from your home [Visits 4, 6, 8, and 10]), and an End of Study Visit (1 visit). The End of Study Visit (Visit 12) will occur in the study clinic.
Armata Pharmaceuticals, Inc. (Armata) has begun a study of an investigational drug (also known as the "study drug") called AP-PA02 as a possible treatment for individuals with cystic fibrosis (CF) and chronic pulmonary Pseudomonas aeruginosa (Pa) infection. The main purposes of this study are to learn about how safe and how well tolerated the study drug is compared to the placebo. This study has two parts, Part 1 and Part 2. You may only participate in Part 1 or Part 2, not both. If you participate in Part 1 of the study, the screening period is up to 21 days, and the on-study period is 29 days, for a total of up to 50 days, and you will need to come to the study center 8 times over this study period. If you are in Part 2 of the study, the screening period is up to 21 days, and the on-study period is 31 days, for a total of up to 52 days, and you will need to come to the study center 10 times over this study period. This study will take place in approximately 12 centers in the United States with about 48 people with CF and chronic Pa participating.
This is a randomized, double-blind, placebo-controlled, active comparator study in eligible subjects with a new diagnosis of MAC lung infection. The purpose of this study is to validate a patient-reported outcomes questionnaire in newly diagnosed subjects given amikacin liposome inhalation suspension (ALIS) as part of a study treatment regimen for NTM caused by MAC. This study will also evaluate the safety and efficacy of the study treatments with ALIS inhalation therapy, azithromycin (AZI) and ethambutol (ETH). Around 100 subjects 18 years and above of age with newly diagnosed NTM caused by MAC are expected to participate in this study. The study will last around 9.5 months from the Screening visit to the end of the study.
The purpose of this study is to evaluate the effect and safety of amikacin liposome inhalation suspension (ALIS) study treatment on patient-reported symptoms in subjects newly diagnosed with NTM lung infection caused by MAC who have not started standard treatment. Around 250 subjects 18 years and older with newly diagnosed NTM lung infection caused by MAC who have not started standard treatment are expected to participate in this study. The study will last around 17.5 months from the Screening visit to the end of the study.
This clinical study is testing the safety (if there are side effects) and tolerability of CB-280 in approximately 32 subjects with CF. This study is being conducted to indentify which CB-280 doses are safe to take without causing too many side effects. CB-280 is an investigational drug that is taken by mouth that blocks an enzyme called arginase, which is thought to play an important role in promoting lung infection in cystic fibrosis (CF). Participation in the study will be up to 56 days long.
The purpose of this research study is to collect phlegm and blood to learn more about the presence of bacteria in patients with Cystic Fibrosis (CF) or Non-Cystic Fibrosis Bronchiectasis (NCFB). This exploratory research study does not involve the administration of any medication. There are approximately 4 visits (1 visit to see for subject eligibility, and 3 visits during the study) to complete the study participation. The study will take two months. About 100 subjects will take part study-wide.
The Medical University of South Carolina (MUSC) is developing a COVID-19 biorepository which will contain blood, urine, and other bodily fluids along with relevant medical information from individuals evaluated, exposed to, or treated for COVID-19. To learn from this pandemic ,and to develop treatments and strategies to better prepare and avert future pandemics we must study the disease and its effects. The clinical specimens in the biorepository will be available for investigators to use for future research. Compensation is provided for participation in this project for eligible participants.
This study is designed to evaluate ABBV-3067 alone and in combination with ABBV-2222 to see how safe they are and how well they work for treating cystic fibrosis. The study will also help select the minimum effective dose of both medicines. Both drugs are investigational and will be taken orally. Both help to restore Cystic Fibrosis transmembrane conductance regulator (CFTR) activity, which is when there isn't enough water on membrane surfaces for those who have cystic fibrosis. You will either receive the drug or a placebo. The study will be done in approximately 3 months. Approximately 189 patients with cystic fibrosis who are older than 18 years of age will be enrolled in this study.
The goal of this cohort and biorepository is to collect data and blood specimens on individuals with Nontuberculous Mycobacteria (NTM), pulmonary disease, and healthy adults to better understand the illness and ultimately improve the care and survival of those with these conditions.