Trial reportJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2021
Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection.
Trial report in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01316276 (Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation), which is not on this map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
Who cites it
15 citing papers in PubMed, 26 citations in OpenAlex.
- The Impact of Surfactants in Tailoring Nanostructured Lipid Carriers for Inhaled Levofloxacin.ACS omega · 2026Article
- Inhalable Nanotechnology-Based Drug Delivery Systems for the Treatment of Inflammatory Lung Diseases.Pharmaceutics · 2025Review
- Nanotechnology-Based Therapeutics for Airway Inflammatory Diseases.Clinical reviews in allergy & immunology · 2025Review
- Pulmonary Delivery of Antibiotics to the Lungs: Current State and Future Prospects.Pharmaceutics · 2025Review
- Liposome-Based Nanoparticle Delivery Systems for Lung Diseases: Opportunities and Challenges.International journal of nanomedicine · 2025Review
- Advances in Targeted Engineered Nanoparticle-Based Therapeutics for Respiratory Diseases: Current Insights and Future Perspectives.International journal of nanomedicine · 2025Review
- Antibiotic treatment of bacterial lung infections in cystic fibrosis.European journal of pediatrics · 2024Review
- Nano-Formulations for Pulmonary Delivery: Past, Present, and Future Perspectives.Pharmaceutics · 2024Review
- Aerosol pulmonary immune engineering.Advanced drug delivery reviews · 2023Review
- Anti-Microorganisms · 2023Review
- Current and Emerging Inhaled Antibiotics for Chronic PulmonaryAntibiotics (Basel, Switzerland) · 2023Review
- Early-Phase Adverse Effects and Management of Liposomal Amikacin Inhalation for RefractoryInfection and drug resistance · 2022Article
- Review
- Itaconic Acid Increases the Efficacy of Tobramycin againstPharmaceutics · 2020Article
- Nanomedicine Fight against Antibacterial Resistance: An Overview of the Recent Pharmaceutical Innovations.Pharmaceutics · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 11 institutions in 8 countries.
Funding
Abstract
background. In CLEAR-108-a phase 3, randomised, open-label study-once-daily amikacin liposome inhalation suspension (ALIS) was noninferior to twice-daily tobramycin inhalation solution (TIS) in improving lung function in patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection after 3 treatment cycles (28 days on/28 days off). The CLEAR-110 extension study (ClinicalTrials.gov: NCT01316276; EudraCT: 2011-000443-24) assessed long-term safety, tolerability, and efficacy of ALIS in eligible patients who completed CLEAR-108.
methods. Patients received once-daily ALIS 590 mg for 12 treatment cycles (96 weeks). Patients were grouped by prior treatment: the "prior-ALIS" cohort received ALIS in CLEAR-108, and the "ALIS-naive" cohort received TIS in CLEAR-108.
results. Overall, 206 patients (prior-ALIS, n=92; ALIS-naive, n=114) entered CLEAR-110 and received ≥1 dose of ALIS. Most patients (88.8%) experienced ≥1 treatment-emergent adverse event (TEAE) through day 672 (end of year 2). Most TEAEs (72.3%) were mild or moderate in severity. Severe TEAEs were reported in 31 patients (15.0%). Two life-threatening TEAEs (haemoptysis; intestinal obstruction) and 1 death (cardiac failure) were reported. Twenty-one patients (10.2%) discontinued treatment due to a TEAE (mostly infective pulmonary exacerbation of CF). Mean change from baseline in forced expiratory volume in 1 second percent predicted at day 672 was -3.1% (prior-ALIS, -4.0%; ALIS-naive, -2.3%). Mean change from baseline in sputum density of P. aeruginosa at day 672 was 0.02 (prior-ALIS, -0.16; ALIS-naive, 0.19) log CFU/g.
conclusions. Long-term treatment with ALIS was well tolerated with a favourable adverse event profile and demonstrated continued antibacterial activity in CF patients with chronic P. aeruginosa infection.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.