Status:
COMPLETED
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
Lead Sponsor:
Insmed Incorporated
Conditions:
Bronchiectasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 infecti...
Detailed Description
Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00775138
Start Date
June 24 2008
End Date
May 11 2009
Last Update
July 10 2019
Active Locations (18)
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1
Washington D.C., District of Columbia, United States
2
Philadelphia, Pennsylvania, United States
3
Sofia, Bulgaria
4
Athens, Greece