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

Completed · Phase 2 · Has a placebo group

Conditions studied: Bronchiectasis

In brief

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.

Key facts

Study ID

NCT00775138

Run by

Insmed Incorporated

People needed

64

Starts

2008-06-24

Expected to finish

2009-05-11

Last updated by the study team

2019-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Sofia, Bulgaria
• Study site — Athens, Greece
• Study site — Mosdós, Hungary
• Study site — Bangalore, India
• Study site — Hyderabad, India
• Study site — Manipal, India
• Study site — Mumbai, India
• Study site — Nagpur, India
• Study site — New Delhi, India
• Study site — Rabka-Zdrój, Poland
• Study site — Belgrade, Serbia
• Study site — Kragujevac, Serbia
• Study site — Niš, Serbia
• Study site — Kiev, Ukraine
• Study site — Cambridge, United Kingdom
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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