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Liposomal Antibiotic

ALIS for Nontuberculous Mycobacterial Infections (ENCORE Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You have not had a lung transplant.
You do not have a disease called cystic fibrosis.
Must not have
You need to be an adult and at least 18 years old (19 years in South Korea and 20 years in Japan).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 15
Awards & highlights

ENCORE Trial Summary

This trial is testing if a new inhaler medication is better than the current one for treating a lung disease.

Eligible Conditions
  • Nontuberculous Mycobacterial Infections

ENCORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

ENCORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Respiratory Symptom Score at Month 13
Secondary outcome measures
Change from Baseline in Fatigue Symptom Score at Month 13
Number of Participants Who Experience an Adverse Event (AEs)
Percentage of Participants Achieving Culture Conversion During Treatment
+9 more

ENCORE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALIS + Background RegimenExperimental Treatment3 Interventions
Participants will be administered 590 mg of ALIS (amikacin liposome inhalation suspension) once daily. Participants will also be administered azithromycin 250 mg and ethambutol 15 mg/kg, once daily.
Group II: ELC + Background RegimenPlacebo Group3 Interventions
Participants will be administered ELC (empty liposome control), a visually matching placebo to ALIS (amikacin liposome inhalation suspension), once daily. Participants will also be administered azithromycin 250 mg and ETH (ethambutol) 15 mg/kg, once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALIS
2020
Completed Phase 3
~100
Azithromycin
2018
Completed Phase 4
~274950
Ethambutol
2023
Completed Phase 4
~3090

Find a Location

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
6,952 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has ALIS received government sanctioning for public use?

"There is some evidence garnered from past trials to support the efficacy of ALIS, as well as data collected from multiple rounds of testing that affirms its safety. Consequently, we have rated it a 3 on our Power scale."

Answered by AI

How many patients are being enrolled in this research project?

"In order to run this study, we need to enroll 250 patients that fit the bill in terms of pre-existing medical conditions and other factors. Our participating locations include USA015 in Altoona, Pennsylvania and USA064 in Lexington, Kentucky."

Answered by AI

Are there precedents for this sort of medication testing?

"There are currently 73 different ongoing clinical trials researching ALIS. Of these, 23 have progressed to Phase 3 testing. Most of the research is being conducted in Chiayi and Hessen; however, there are a total of 772 locations running trials for this treatment across the globe."

Answered by AI

In how many different locations is this research being conducted?

"Enrolment for this trial is currently underway at 69 different locations, which include cities such as Altoona, Lexington and Tyler. If you are considering enrolling in the study, try to choose a site that is close to your location to limit travel requirements."

Answered by AI

What medical conditions is ALIS most often used as a treatment for?

"ALIS is most often used to treat infections in the abdomen. It can also be given to patients who, after at least 6 months of multidrug therapy, still have positive sputum cultures or those with neonatal sepsis or genus chlamydia."

Answered by AI

Are there any available positions for participants in this trial?

"Yes, this study is still open to new participants according to the latest update on clinicaltrials.gov. The listing was first posted on 4/1/2021 and last edited on 11/7/2022."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Ohio
California
Other
What site did they apply to?
USA037
University of California San Diego Medical Center
University of California Davis Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

i got copd. I saw a advert. I have emphysema. I was just curious. Help with Research.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Can I help do this? Yes can I be helped? Does this trial pay? do you have to have MAC?
PatientReceived no prior treatments
How do the screening interviews take?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. National Jewish Health: < 24 hours
  2. Centricity Research - Roswell - HyperCore - PPDS: < 24 hours
  3. University of Cincinnati: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
2021. "Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04677569.
All > Mac
~62 spots leftby Apr 2025
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