Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence of chronic Pseudomonas aeruginosa infections. The Pseudomonas aeruginosa 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 (Arikace™) was developed as a possible treatment for chronic infection due to Pseudomonas aeruginosa in CF patients.

The purpose of this double-blind, placebo controlled study is to determine whether Arikace™ is effective in treating chronic lung infections caused by Pseudomonas aeruginosa in Cystic Fibrosis subjects. The study will enroll approximately 300 subjects in clinics in the US, Canada, Europe, Australia and New Zealand. Subjects will be randomized to 590 mg Arikace™ or placebo and will receive treatment for 28 days followed by a 56 day safety follow-up period. The subjects will be required to visit the clinic 8 times (including the Screening visit) over a period of approximately 3 months. No overnight stays at the clinic will be required. At the completion of the TR02-109 protocol, subjects who have consented and meet study safety criteria may enroll in the long-term, open-label, multi-cycle extension study of 590 mg of Arikace™ (under a separate protocol TR02-110).

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

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Amikacin

Criteria

Key Inclusion Criteria:

• Written informed consent or assent

• Confirmed diagnosis of CF

• History of chronic infection with Pseudomonas aeruginosa

• History of documented pulmonary exacerbation requiring treatment with antibiotics in the 12 months prior to Screening

• Sputum culture positive for Pseudomonas aeruginosa at Screening

• FEV1 ≥ 25% of predicted value at Screening

Key Exclusion Criteria:

• FEV1 <25% of predicted value at Screening

• History of hypersensitivity to aminoglycosides

• History of major complications of lung disease (including atelectasis, pneumothorax, major pleural effusion) within 8 weeks prior to Screening

• Hemoptysis of ≥60 mL in a 24-hour period within 4 weeks 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 requiring systemic steroid treatment 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

• Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within one year prior to Screening or anticipated during the study period

• 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