Study of Arikace™ for Treatment of Bronchiectasis (Protocol TR02-107)

• Research type

  Research Study

• Full title

  A Placebo Controlled, Randomized, Parallel Cohort, Safety And Tolerability Study Of Two Dose Levels Of Liposomal Amikacin For Inhalation (Arikace™) In Patients With Bronchiectasis Complicated By Chronic Infection Due To Pseudomonas Aeruginosa

• Contact name

  Diana Bilton

• Sponsor organisation

  Transave, Inc.

• Eudract number

  2007-007940-92

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study investigates the use of an inhaled antibiotic called liposomal amikacin in people with a chronic airway disease called bronchiectasis. The aim of the study is to establish whether patients with bronhiectasis can tolerate the new investigational drug and to ensure there are no unacceptable side effects. In addition, the usefulness of this new inhalational antibiotic will be tested by measuring the change in numbers of bacteria in sputum of the patients. Patients will be recruited in a stable phase of their disease and will either receive the investigational product in one of two doses or placebo (an inactive substance). A total of 60 patients will be recruited from 9 countries. The treatment will be administered for 28 days, and patients will be followed for an additional 28 days. After the end of the study, there will be an additional 6 month follow up (conducted by telephone contacts) to assess the number of exacerbations occurring after the dosing period.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  08/H0505/144

• Date of REC Opinion

  12 Dec 2008

• REC opinion

  Further Information Favourable Opinion