A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients
Background: Inhaled antibiotics are standard of care for persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa airway infection. APT-1026 (levofloxacin inhalation solution, LIS) is fluoroquinolone in development. We compared the safety and efficacy of LIS to tobramycin inhalation so...
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| Format: | Article |
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Elsevier
2015
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| Online Access: | https://eprints.nottingham.ac.uk/31682/ |
| _version_ | 1848794252208766976 |
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| author | Elborn, J. Stuart Geller, David E. Conrad, Douglas Aaron, Shawn D. Smyth, Alan R. Fischer, Rainald Kerem, Eitan Bell, Scott C. Loutit, Jeffery S. Dudley, Michael N. Morgan, Elizabeth E. VanDevanter, Donald R. Flume, Patrick |
| author_facet | Elborn, J. Stuart Geller, David E. Conrad, Douglas Aaron, Shawn D. Smyth, Alan R. Fischer, Rainald Kerem, Eitan Bell, Scott C. Loutit, Jeffery S. Dudley, Michael N. Morgan, Elizabeth E. VanDevanter, Donald R. Flume, Patrick |
| author_sort | Elborn, J. Stuart |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Background: Inhaled antibiotics are standard of care for persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa airway infection. APT-1026 (levofloxacin inhalation solution, LIS) is fluoroquinolone in development. We compared the safety and efficacy of LIS to tobramycin inhalation solution (TIS) in persons ≥12 years old with CF and chronic P. aeruginosa infection.
Methods: This multinational, randomized (2:1), non-inferiority study compared LIS and TIS over three 28-day on/off cycles. Day 28 FEV1 % predicted change was the primary endpoint. Time to exacerbation and patient-reported quality of life superiority were among secondary endpoints.
Results: Baseline demographics for 282 subjects were comparable. Non-inferiority was demonstrated (1.86% predicted mean FEV1 difference [95% CI −0.66 to 4.39%]). LIS was well-tolerated, with dysguesia (taste distortion) the most frequent adverse event.
Conclusions: LIS is a safe and effective therapy for the management of CF patients with chronic P. aeruginosa. |
| first_indexed | 2025-11-14T19:13:14Z |
| format | Article |
| id | nottingham-31682 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:13:14Z |
| publishDate | 2015 |
| publisher | Elsevier |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-316822020-05-04T17:01:05Z https://eprints.nottingham.ac.uk/31682/ A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients Elborn, J. Stuart Geller, David E. Conrad, Douglas Aaron, Shawn D. Smyth, Alan R. Fischer, Rainald Kerem, Eitan Bell, Scott C. Loutit, Jeffery S. Dudley, Michael N. Morgan, Elizabeth E. VanDevanter, Donald R. Flume, Patrick Background: Inhaled antibiotics are standard of care for persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa airway infection. APT-1026 (levofloxacin inhalation solution, LIS) is fluoroquinolone in development. We compared the safety and efficacy of LIS to tobramycin inhalation solution (TIS) in persons ≥12 years old with CF and chronic P. aeruginosa infection. Methods: This multinational, randomized (2:1), non-inferiority study compared LIS and TIS over three 28-day on/off cycles. Day 28 FEV1 % predicted change was the primary endpoint. Time to exacerbation and patient-reported quality of life superiority were among secondary endpoints. Results: Baseline demographics for 282 subjects were comparable. Non-inferiority was demonstrated (1.86% predicted mean FEV1 difference [95% CI −0.66 to 4.39%]). LIS was well-tolerated, with dysguesia (taste distortion) the most frequent adverse event. Conclusions: LIS is a safe and effective therapy for the management of CF patients with chronic P. aeruginosa. Elsevier 2015-01-13 Article PeerReviewed Elborn, J. Stuart, Geller, David E., Conrad, Douglas, Aaron, Shawn D., Smyth, Alan R., Fischer, Rainald, Kerem, Eitan, Bell, Scott C., Loutit, Jeffery S., Dudley, Michael N., Morgan, Elizabeth E., VanDevanter, Donald R. and Flume, Patrick (2015) A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. Journal of Cystic Fibrosis, 14 (4). pp. 507-514. ISSN 1873-5010 cystic fibrosis antibiotics Pseudomonas aerosol fluoroquinolone http://www.sciencedirect.com/science/article/pii/S1569199314003105 doi:10.1016/j.jcf.2014.12.013 doi:10.1016/j.jcf.2014.12.013 |
| spellingShingle | cystic fibrosis antibiotics Pseudomonas aerosol fluoroquinolone Elborn, J. Stuart Geller, David E. Conrad, Douglas Aaron, Shawn D. Smyth, Alan R. Fischer, Rainald Kerem, Eitan Bell, Scott C. Loutit, Jeffery S. Dudley, Michael N. Morgan, Elizabeth E. VanDevanter, Donald R. Flume, Patrick A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients |
| title | A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients |
| title_full | A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients |
| title_fullStr | A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients |
| title_full_unstemmed | A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients |
| title_short | A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients |
| title_sort | phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (apt-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients |
| topic | cystic fibrosis antibiotics Pseudomonas aerosol fluoroquinolone |
| url | https://eprints.nottingham.ac.uk/31682/ https://eprints.nottingham.ac.uk/31682/ https://eprints.nottingham.ac.uk/31682/ |