ARD-3150-1202: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4)
Sponsor: |
Aradigm Corporation |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAN6253 |
U.S. Govt. ID: |
NCT02104245 |
Contact: |
Kristina Rivera: 212-305-4675 / klr2142@columbia.edu |
The purpose of this study is to assess how effective the study drug Pulmaquin is in the management of chronic lung infections with Pseudomonas aeruginosa in subjects with non cystic fibrosis (nonCF) bronchiectasis by evaluating the time to first pulmonary exacerbation. A pulmonary exacerbation is defined as the new appearance or worsening in 4 or more of already present specific respiratory signs and symptoms including: cough, wheezing, chest congestion or shortness of breath, fever (38C or 98.6F), exercise tolerance and lung function tests, malaise, fatigue or lethargy, chest sounds, sputum production and x-ray findings of the lung.
This study is closed
Investigator
Emily DiMango, MD
Do you have a confirmed diagnosis of non-CF bronchiectasis? |
Yes |
No |
Do you have a history of Pseudomonas aeruginosa respiratory infections? |
Yes |
No |
Have you had at least two pulmonary exacerbations treated with antibiotics in the previous year? |
Yes |
No |