Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02628600




Registration number
NCT02628600
Ethics application status
Date submitted
8/12/2015
Date registered
11/12/2015
Date last updated
10/02/2020

Titles & IDs
Public title
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
Scientific title
An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients With Nontuberculous Mycobacterial (NTM) Lung Infections Caused by Mycobacterium Avium Complex (MAC) That Are Refractory to Treatment
Secondary ID [1] 0 0
2015-003170-33
Secondary ID [2] 0 0
INS-312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NTM Lung Infection Due to MAC 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LAI 590 mg
Treatment: Drugs - Multi-drug regimen

Experimental: Prior LAI + Multidrug Regimen - Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.

Experimental: Prior Multidrug Regimen Alone - Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.


Treatment: Drugs: LAI 590 mg
LAI 590 mg QD: administered by inhaling drug product that had been aerosolized in an investigational eFlow nebulizer over approximately 14 minutes

Treatment: Drugs: Multi-drug regimen
Multidrug antimycobacterial regimen from study INS-212
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From baseline to 28 days after end of treatment, up to 13 months
Secondary outcome [1] 0 0
Number of Participants Achieving Culture Conversion by Month 6 and Month 12
Timepoint [1] 0 0
by Month 6 and Month 12
Secondary outcome [2] 0 0
Time to Culture Conversion
Timepoint [2] 0 0
by Month 12
Secondary outcome [3] 0 0
Change From Baseline (Day 1) to Month 6 and Month 12 in the 6MWT Distance
Timepoint [3] 0 0
From baseline to Month 12 or end of treatment

Eligibility
Key inclusion criteria
Key

1. had successfully completed the Month 6 and End of Treatment visits in Study INS-212

2. had not achieved the INS-212 protocol definition of culture conversion by Month 6 in
Study INS-212 OR had experienced a relapse or recurrence by Month 6 in Study INS-212.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. achieved culture conversion without relapse or recurrence in the Study INS-212 study by
Month 6

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2018
Sample size
Target
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Insmed Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label safety extension study to assess the safety and tolerability of once
daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen
in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium
avium complex (MAC) who were refractory to therapy and failed to convert in Study INS-212
(NCT02344004).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02628600
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Kevin Mange, MD
Address 0 0
Insmed Incorporated
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries