Phase 3
Completed N=206
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
Source: ClinicalTrials.gov NCT01316276 ↗Enrolled (actual)
206
Serious AEs
44.7%
Results posted
Jul 2019
Primary outcomePrimary: Treatment Emergent Adverse Events (TEAEs) up to Day 672 — 183; 92; 21 Participants
◆ Published Evidence
Established
26citations · ~5 / year
Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection.
Summary
The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.
Linked Publications
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Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Emergent Adverse Events (TEAEs) up to Day 672 |
183; 92; 21 | — |
| PRIMARY Laboratory Abnormalities up to Day 672 |
13; 8; 8; 7; 12; 23 | — |
| PRIMARY Acute Tolerability as Measured by Pulmonary Function Test (PFT) Changes Pre to Post Dose |
6; 6; 1; 5; 5; 6 | — |
| PRIMARY Respiratory Rate: Change From Baseline to Day 672 |
-0.8 | — |
| PRIMARY Heart Rate: Change From Baseline From Day 672 |
-0.9 | — |
| PRIMARY Systolic BP: Change From Baseline at Day 672 |
2.3 | — |
| PRIMARY Diastolic BP: Change From Baseline at Day 672 |
1.5 | — |
| PRIMARY Body Temperature: Change From Baseline at Day 672 |
0.03 | — |
| PRIMARY Oxygen Saturation: Change From Baseline at Day 672 |
-0.1 | — |
| PRIMARY Minimum Inhibitory Concentrations (MICs) for Pseudomonas Aeruginosa (Pa) and Burkholderia Species From Day 1 to Days 169, 337, 505 and 672 |
16.000; 16.000; 16.000; 16.000; 16.000; 2.000 | — |
| PRIMARY Evaluation of Audiology |
133; 2; 0; 0; 0; 26 | — |
| PRIMARY Change in Serum Creatinine Throughout the Study |
1; 205; 0; 158; 0; 131 | — |
| SECONDARY Percent Change in FEV1 Throughout the Study |
2.104; 2.36; 3.62 | — |
| SECONDARY Number of Subjects Experiencing a Protocol Defined Pulmonary Exacerbation |
151; 55 | — |
| SECONDARY Number of Subjects Initiating Treatment. |
81; 108 | — |
| SECONDARY Number of Participants Who Received Antipseudomonal Antibiotic Treatment for Protocol Defined Pulmonary Exacerbation |
148; 58 | — |
Eligibility Criteria
Key Inclusion Criteria
- Written informed consent or assent
- Subject has completed study TR02-108, and has been compliant with the study protocol
- Women of childbearing potential must agree to use reliable methods of contraception for the duration of the study
Key Exclusion Criteria
- Subject met any of the listed criteria for study drug discontinuation in protocol TR02-108.
- Abnormal laboratory assessments including LFT (≥ 3× upper limit of normal [ULN]), serum creatinine (> 2× ULN) and absolute neutrophil count [ANC] (< 1000).
- Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
- History of alcohol, medication or illicit drug abuse within the 6 months prior to consent.
- Smoking tobacco or any substance within 6 months prior to consent or anticipated inability to refrain from smoking throughout the study
Data sourced from ClinicalTrials.gov (NCT01316276) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.