Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
Condition: Bronchiectasis
MeSH terms: Infections; Pseudomonas Infections; Persistent Infection; Bronchiectasis
Intervention: 280 mg Arikayce™; Matching Placebo for Cohort 1; 560 mg Arikayce™; Matching Placebo for Cohort 2
Intervention description: Study subjects will receive Arikace™ 280 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.; Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.; Study subjects will receive Arikace™ 560 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.; Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
Intervention MeSH terms: Amikacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bronchiectasis; Respiratory Infections; Amikacin; Respiratory Tract Diseases; Respiratory Tract Infections; Lung Diseases; Pseudomonas aeruginosa; Amikacin liposome inhalation suspension (ALIS)

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female study subjects≥ 18 years of age

          -  Confirmed diagnosis of multi-focal bronchiectasis in two or more lung segments by HRCT
             of the chest

          -  History of chronic infection with P. aeruginosa

          -  Confirmation of infection with P. aeruginosa at screening

          -  SaO2 ≥ 90% at Screening while breathing room air

          -  Ability to comply with study medication use, study visits, and study procedures as
             judged by the investigator

          -  Ability to produce at least 0.5 grams sputum or be willing to undergo an induction to
             produce sputum for clinical evaluation

        Key Exclusion Criteria:

          -  Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted at Screening

          -  Patients with hemoptysis of ≥60 mL within 4 weeks prior to screening

          -  Bronchiectasis due to cystic fibrosis (CF), bronchopulmonary Aspergillus, aspiration
             of foreign body, or secondary to lung compression from tumors

          -  History of non-tuberculous mycobacterial and/or Aspergillus infection requiring
             treatment or treated within 2 years prior to screening

          -  Pulmonary tuberculosis requiring treatment or treated within two years prior to
             screening

          -  History of Lung transplantation

          -  Use of any inhalation or systemic antibiotics (IV antibiotics, or oral antibiotics)
             within 4 weeks prior to Study Day 1

          -  Evidence of biliary cirrhosis with portal hypertension

          -  Smoking tobacco or any substance within 6 months prior to screening, and throughout
             the study

          -  History of alcohol, medication, or illicit drug abuse within the 1 year prior to
             screening