Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections

• Status: Completed
• Trial end date: 2013-09-18
• Target enrollment: 0
• Participant gender: All

Summary

A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients.

The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Amikacin; Pharmaceutical Solutions; Tobramycin

Criteria

Key Inclusion Criteria:

• Written informed consent or assent

• Confirmed diagnosis of CF

• History of chronic infection with Pseudomonas aeruginosa

• Sputum culture positive for Pseudomonas aeruginosa at Screening

• FEV1 ≥ 25% of predicted value at Screening

Key Exclusion Criteria:

• FEV1 <25% of predicted at Screening

• History of major complications of lung disease within 8 weeks prior to Screening

• Hemoptysis of ≥60 mL in a 24-hour period within 4 weeks prior to Screening

• History of positive culture for Burkholderia cepacia within 2 years prior to Screening

• History of pulmonary tuberculosis or non-tuberculous mycobacterial lung disease treated within 2 years prior to Screening or requiring treatment at the time of screening

• History of Allergic Broncho-Pulmonary Aspergillosis or any other condition requiring systemic steroids at a dose ≥ equivalent of 10 mg/day of prednisone within 3 months prior to Screening

• Presence of any clinically significant cardiac disease

• History of lung transplantation

• Daily, continuous oxygen supplementation or nighttime supplemental oxygen requirement of greater than 2 L/min

• Administration of any investigational products within 8 weeks prior to study Day 1

• Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study