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.
The SIMPLIFY study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline or Pulmozyme® (dornase alfa) in those people that are also taking Trikafta™. The SIMPLIFY studyl consists of two similar studies conducted within the same protocol that are being done to answer the following questions:
• Study A: For people with CF taking Trikafta, does stopping treatment with hypertonic saline (at least 3%) have a similar effect on lung function as continuing treatment with hypertonic saline?
• Study B: For people with CF taking Trikafta, does stopping treatment with Pulmozyme have a similar effect on lung function as continuing treatment with Pulmozyme?
There are a total of 4 study visits (a screening visit and three additional visits during the active part of the study). There is a 2-week screening period and a 6-week active study period.About 920 people with CF who are 12 years of age or older will take part in this study at approximately 80 hospitals and clinics around the country. Of this total, approximately 520 people will participate in the hypertonic saline (Study A) portion and 400 people with participate in the Pulmozyme (Study B) portion 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 purpose of this study is to learn more about the effectiveness and safety of the investigational drug called fenretinide (LAU-7b). The FDA has approved the testing of fenretinide in this study. Researchers hope that treatment with fenretinide will preserve lung function by reducing the persistent inflammation in the lung and to improve its capacity to defend against bacteria such as Pseudomonas aeruginosa. The drug will be administered by capsules. Your participation in this study will last approximately 7 months and includes 8 study visits to the study center (which will last approximately 2-5 hours) and 6 telephone calls. The phone calls are expected to last 10-15 minutes and depend on the amount of information you report.
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 main purpose of this study is to see if important factors can be identified in each of the three categories (patient, catheter, and catheter management) that are linked to blood clotting complications. This is a multicenter, prospective observational study to evaluate risk factors associated with complications of peripherally inserted central catheter (PICCs) and midline catheters. Both adult and pediatric patients with CF who receive care at participating centers will be eligible for participation. This study can last for 2 weeks.
This is an observational study which will collect sweat chloride values from approximately 1000 cystic fibrosis subjects who are currently on cystic fibrosis transmembrane conductance regulator (CFTR) modulators. This study will require one visit to an MUSC clinic which will last approximately 2 hours. Compensation is provided.
This study has two parts and will assess your hearing and the potential effects of antibiotic-induced ototoxicity. Ototoxicity is a potential effect of drugs used to treat your lung infections, and its effect on your ears (oto=ears), particularly structures in your inner ear that enable hearing and balance. Part One of the study will assess your inner ear function that may be associated with hearing loss and / or loss of balance in cystic fibrosis patients taking tobramycin. Part Two is looking to determine if SPI-1005, an investigational drug, influences hearing loss, due to mediations (tobramycin).