CLINICAL TRIALS PROFILE FOR ARIKAYCE KIT
✉ Email this page to a colleague
All Clinical Trials for ARIKAYCE KIT
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00558844 ↗ | Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Completed | Insmed Incorporated | Phase 1/Phase 2 | 2008-01-01 | This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF) and chronic infection due to pseudomonas aeruginosa. |
| NCT00775138 ↗ | Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa. | Completed | Insmed Incorporated | Phase 2 | 2008-06-24 | This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection. |
| NCT00777296 ↗ | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) | Completed | Insmed Incorporated | Phase 1/Phase 2 | 2007-02-22 | A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation (Arikace™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of subjects infected via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug in close proximity to the bacterial colonies, thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating CF subjects with chronic infection caused by P. aeruginosa. |
| NCT01315236 ↗ | Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 2012-04-19 | The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease. The first part of the study is the 84-day double-blind phase to evaluate the primary and secondary endpoints. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for ARIKAYCE KIT
Condition Name
Clinical Trial Locations for ARIKAYCE KIT
Trials by Country
Clinical Trial Progress for ARIKAYCE KIT
Clinical Trial Phase
Clinical Trial Sponsors for ARIKAYCE KIT
Sponsor Name
