A severe lung disease in need of new and improved treatment options
Pulmonologists from major medical centers across the world are recruiting patients with non-cystic fibrosis bronchiectasis (BE) to participate in two clinical trials with Pulmaquin.
Patients with BE who have chronic respiratory infections with the microorganism Pseudomonas aeruginosa have a severe form of the disease that can lead to poor quality of life and untimely death. BE is a condition characterized by abnormal dilatation of the airways, often associated with chronic infection. The patient’s lung function is often irreversibly reduced compared to that found in healthy individuals.
BE is frequently observed in patients with cystic fibrosis (CF). However, it is a condition that affects over 100,000 people without CF in the United States. Many of these patients are non-smokers and the origin of their BE is unknown.
Two international clinical research studies are underway to evaluate the safety and effectiveness of Pulmaquin®, an investigational drug that is inhaled once daily. The trials compare Pulmaquin to placebo in the management of chronic lung infections with P. aeruginosa in patients with non-cystic fibrosis BE.
Investigators will evaluate this by determining how long it takes for participants to experience their first pulmonary exacerbation. A pulmonary exacerbation is the new appearance or worsening of respiratory signs and symptoms such as cough, wheezing, chest congestion or shortness of breath, fever, or fatigue. Other important clinical endpoints, including the patients’ quality of life will also be evaluated.
These clinical research trials will be enrolling over 500 subjects over the age of 18. Enrolled subjects will visit the study center monthly for approximately 1 year with two thirds of the subjects taking Pulmaquin and one third placebo. Participants who complete this phase of their study will then participate in a 4-week extension in which all subjects will be given the investigational drug Pulmaquin®.
Study centers are seeking individuals to participate in these clinical trials. Only those patients meeting the pre-defined inclusion/exclusion criteria are eligible for the clinical trials.