Phase 3
Completed N=336
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
Mycobacterium Infections, Nontuberculous
Source: ClinicalTrials.gov NCT02344004 ↗
Enrolled (actual)
336
Serious AEs
20.3%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants Achieving Culture Conversion by Month 6 in the Liposomal Amikacin for Inhalation (LAI) + Multi-drug Regimen (MDR) Arm Compared to the MDR Alone Arm — 65; 10; 159; 102 Participants — p=<0.0001
◆ Published Evidence
Highly cited
343citations · ~43 / year
Amikacin Liposome Inhalation Suspension for Treatment-Refractory Lung Disease Caused by <i>Mycobacterium avium</i> Complex (CONVERT). A Prospective, Open-Label, Randomized Study.
Summary
A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) 590 mg administered once daily (QD) when added to multi-drug regimen (MDR) in participants with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC) that were refractory to treatment.
Participants were randomized 2:1 to LAI 590 mg administered QD + MDR or MDR alone.
Linked Publications (5)
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Amikacin Liposome Inhalation Suspension for Treatment-Refractory Lung Disease Caused by <i>Mycobacterium avium</i> Complex (CONVERT). A Prospective, Open-Label, Randomized Study.
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Amikacin Liposome Inhalation Suspension for Refractory Mycobacterium avium Complex Lung Disease: Sustainability and Durability of Culture Conversion and Safety of Long-term Exposure.
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Population Pharmacokinetic Evaluation of Amikacin Liposome Inhalation Suspension in Patients with Treatment-Refractory Nontuberculous Mycobacterial Lung Disease.
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Amikacin liposome inhalation suspension for Mycobacterium avium complex pulmonary disease: A subgroup analysis of Japanese patients in the randomized, phase 3, CONVERT study.
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Management and Resolution of Hypersensitivity Pneumonitis-Related Events in Japanese Patients Treated with Amikacin Liposome Inhalation Suspension in the CONVERT and INS-312 Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Culture Conversion by Month 6 in the Liposomal Amikacin for Inhalation (LAI) + Multi-drug Regimen (MDR) Arm Compared to the MDR Alone Arm |
65; 10; 159; 102 | <0.0001 sig |
| PRIMARY Number of Participants Achieving Durable Culture Conversion Through 3 Months Off Treatment in the LAI + MDR Arm Compared to the MDR Arm Alone |
36; 0; 188; 112 | <0.0001 sig |
| SECONDARY Change From Baseline (Day 1) to Month 6 in the Six-Minute Walk Test (6MWT) Distance in the LAI + MDR Arm Compared to the MDR Alone Arm |
424.2; 420.9; 420.6; 420.3; -3.6; -0.5 | 0.7804 |
| SECONDARY Time to Culture Conversion by Month 6 in the LAI + MDR Arm Compared to the MDR Alone Arm |
2.13; NA; NA; NA | <0.0001 sig |
| SECONDARY Number of Participants Achieving Sustained Culture Conversion at the End of Treatment (EOT) in the LAI + MDR Arm Compared to the MDR Arm Alone |
41; 3; 183; 109 | — |
| SECONDARY Change in 6-Minute Walk Test (6MWT) Distance at EOT in the LAI Arm Compared to a Multi-drug Regimen Alone |
— | — |
| SECONDARY Change From Baseline (Day 1) at Month 6 in the St. George's Respiratory Questionnaire (SGRQ) Total Score |
36.555; 38.409; 38.715; 37.368; 2.009; -1.312 | — |
Eligibility Criteria
Inclusion Criteria
- Be continually positive for MAC on sputum culture while adhering to a multi-drug treatment regimen for a minimum duration of 6 months which is either ongoing or was completed no more than 12 months before screening
- Be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis and/or fibrocavitary disease by chest CT
- Be willing to adhere to multi-drug treatment regimen during the course of the study
Exclusion Criteria
- Patients with cystic fibrosis
- Positive pregnancy test or lactation at screening. All women of child bearing potential will be tested. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally sterile.
- Active pulmonary tuberculosis requiring treatment at screening
- History of lung transplantation
- Prior exposure to LAI (including clinical study).
Data sourced from ClinicalTrials.gov (NCT02344004) 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.