Bronchiectasis Complicated by Chronic Infection due to Pseudomonas aeruginosa MedDRA version: 9.1 Level: LLT Classification code 10006445 Term: Bronchiectasis
Conditions
Interventions
Product Name: Liposomal Amikacin (Arikace™)
Pharmaceutical Form: Nebuliser suspension
INN or Proposed INN: AMIKACIN SULFATE
CAS Number: 39831555
Sponsors
Transave, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent obtained from the patient or legal representative prior to the performance of any study related procedures 2) Male or female study subjects= 18 years of age 3) Confirmed diagnosis of multi-focal bronchiectasis in two or more lung segments by HRCT of the chest 4) History of chronic infection with P. aeruginosa, defined as: At least 1 documented positive culture in the 12 months prior to screening AND One or more documented courses of antibiotics for respiratory tract infection in the past 12 months, including either: One course of IV antibiotics OR One treatment failure with oral antibiotics requiring additional antibiotic treatment for respiratory tract infection 5) Confirmation of infection with P. aeruginosa at screening (defined as mucopurulent sputum positive for P. aeruginosa) 6) SaO2 = 90% at Screening while breathing room air 7) Ability to comply with study medication use, study visits, and study procedures as judged by the investigator 8) Ability to produce at least 0.5 grams sputum or be willing to undergo an induction to produce sputum for clinical evaluation 9) Female of childbearing potential agrees to practice an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Forced Expiratory Volume in 1 second (FEV1) 450 msec (or 0.450 seconds), females QTc> 470 msec (or 0.470 seconds) 13) Use of any inhalation or systemic antibiotics (IV antibiotics, or oral antibiotics) within 4 weeks prior to Study Day 1 14) Initiation of chronic therapy (e.g., TOBI®, high-dose ibuprofen, rhDNase, macrolide antibiotics, chronic suppressive antibacterial treatment) within the 28 days prior to Study Day 1 15) Administration of any investigational drug within 8 weeks prior to screening 16) Hypersensitivity to aminoglycosides 17) Evidence of biliary cirrhosis with portal hypertension 18) AST or ALT = X 3 times the upper limit of normal at Screening 19) Absolute Neutrophil Count = 1000 performed at Screening 20) Serum creatinine > X1.8 times normal performed at Screening 21) History of daily, continuous oxygen supplementation 22) Smoking tobacco or any substance within 6 months prior to screening, and throughout the study 23) History of alcohol, medication, or illicit drug abuse within the 1 year prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of two dose levels of nebulized Arikace™ versus placebo.;Secondary Objective: To evaluate efficacy of two dose levels of nebulized Arikace™ versus placebo.; Primary end point(s): • Treatment emergent adverse events up to end of treatment • Treatment emergent marked laboratory abnormalities up to 28 days after study medication discontinuation • Treatment emergent pulmonary function test (PFT) abnormalities post-dose for acute tolerability assessment • Treatment emergent pulmonary function test (PFT) abnormalities up to end of treatment • Adverse events leading to permanent discontinuation of study medication • Serious adverse events up to 28 days after study medication discontinuation | — |
Countries
Belgium, Bulgaria, Greece, Hungary, United Kingdom
Outcome results
None listed