| Arikayce (amikacin liposome inhalation suspension) / Insmed |
| Completed | 2a | 66 | Europe, RoW | ARIKACE™, liposomal amikacin for inhalation, Arikayce, Placebo | Insmed Incorporated | Cystic Fibrosis | 02/08 | 02/08 | | |
NCT00775138 / 2007-007940-92: Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa. |
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| Completed | 2 | 64 | Europe, US, RoW | 280 mg Arikayce™, liposomal amikacin for inhalation, Matching Placebo for Cohort 1, 560 mg Arikayce™, Matching Placebo for Cohort 2 | Insmed Incorporated | Bronchiectasis | 05/09 | 05/09 | | |
NCT03905642: Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase |
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| Completed | 2 | 49 | Europe, RoW | Arikayce™, Liposomal amikacin inhalation, LAI | Insmed Incorporated | Cystic Fibrosis | 11/10 | 11/10 | | |
NCT01315236: Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria |
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| Completed | 2 | 90 | Canada, US | Liposomal amikacin for inhalation (LAI), Amikacin Liposome Inhalation Suspension (ALIS), Arikayce, placebo | Insmed Incorporated, National Institute of Allergy and Infectious Diseases (NIAID) | Mycobacterium Infections, Nontuberculous | 08/14 | 06/15 | | |
2005-004389-17: SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA |
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| Ongoing | 2 | 10 | Europe | SLIT Amikacin, TR02, | Transave, Inc | Cystic Fibrosis with mild to moderate obstructive lung disease and chronic infection with Pseudomonas aeruginosa | | | | |
NCT03038178: Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease |
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| Completed | 2 | 30 | US | LAI plus multi-drug regimen, ARIKAYCE™ | Kevin Winthrop, Insmed Incorporated, The University of Texas Health Science Center at Tyler | Mycobacterium Infections, Nontuberculous, Mycobacteria, Atypical | 10/19 | 12/19 | | |
NCT00558844: Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa |
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| Completed | 1b/2a | 41 | US | Arikayce™ 560 mg, Placebo for 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg, Placebo for 70 mg / 140 mg | Insmed Incorporated | Cystic Fibrosis | 06/09 | 06/09 | | |
