Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

• Status: Completed
• Trial end date: 2009-05-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Amikacin

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