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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01315691
• Date of registration: 14/03/2011
• Prospective Registration: Yes
• Primary sponsor: Insmed Incorporated
• Public title: Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa
• Scientific title: Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
• Date of first enrolment: February 29, 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01315691
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Contacts

• Name: Gina Eagle, MD
• Affiliation: Insmed Incorporated

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Liposomal amikacin for inhalation

Drug: Placebo for liposomal amikacin for inhalation

Primary Outcome(s)

Time to first protocol defined pulmonary exacerbation [Time Frame: 84 days]

Secondary Outcome(s)

Relative change in FEV1 (liters) and FEV1 (% predicted) [Time Frame: 84 days]

Evaluation of safety and tolerability [Time Frame: 84 days]

Change in Pseudomonas aeruginosa and Burkholderia sp. density in sputum [Time Frame: 84 days]

Proportion of subjects experiencing protocol defined exacerbations [Time Frame: 84 days]

Change in patient reported outcomes/symptoms [Time Frame: 84 days]

Time to first antipseudomonal antibiotic treatment for pulmonary exacerbation [Time Frame: 84 days]

Secondary ID(s)

TR02-109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors