Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone



Status:Active, not recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:May 27, 2015
End Date:April 9, 2019

Use our guide to learn which trials are right for you!

A Randomized, Open-label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients With Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC) That Are Refractory to Treatment

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 subjects with
Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC)
that were refractory to treatment.

Subjects were randomized 2:1 to LAI 590 mg administered QD + MDR or MDR alone.

This is an ongoing randomized, open-label, multicenter study of LAI in adult subjects with
NTM lung infections caused by MAC that were refractory to treatment. Subjects received either
LAI 590 mg administered QD by inhalation plus a multidrug regimen, hereafter referred to as
LAI + MDR or a multidrug regimen alone, hereafter referred to as MDR alone for a minimum of 8
months. Subjects who demonstrated culture conversion by Month 6 went on to complete a
treatment course of 12 months, starting from the first of 3 negative cultures that defined
culture conversion.

Sputum culture results were made available to the site after the Month 6 sputum result was
known, in time for the Month 8 visit. Prior to the Month 8 visit, the culture results from
Baseline to Month 6 inclusively were blinded to the site and Sponsor. The results were
blinded to reduce the potential for bias in an open-label study. At Month 8 (-28 to +7 days),
after all sputum culture results were made available to the site only, up to and including
Month 6, subjects were assessed as converters or non-converters.

A converter was defined as a subject who had 3 consecutive monthly MAC-negative sputum
cultures at any time within the first 6 months of the study.

"Relapse or recurrence" was defined as having MAC-positive sputum cultures in liquid broth
media (agar negative) for 3 or more consecutive months, or having at least 1 MAC-positive
sputum culture on solid media (agar positive) after achieving culture conversion.

A non-converter was defined as a subject who did not have 3 consecutive monthly MAC-negative
sputum cultures at any time within the first 6 months of the study.

All converters remained in the study. Converters who, after culture conversion, subsequently
had MAC-positive sputum cultures in liquid broth media (agar negative) for 1 or 2 consecutive
months only by Month 6 also remained in the study. Subjects who remained in the study
continued their randomized treatment regimen until they completed a total of 12 months of
treatment (EOT), starting from the first of 3 negative cultures that defined culture
conversion. These subjects returned after the EOT visit for 28 days, 3, 6, and 12 months
off-treatment follow-up visits. The 12 months off-treatment follow-up visit was the EOS
visit. No NTM treatment was administered during the off-treatment phase.

At Month 8, all non-converters as assessed at the Month 6 visit were discontinued from Study
INS-212. Subjects who experienced a relapse or recurrence by Month 6 also discontinued from
Study INS-212 at their Month 8 visit. These subjects were potentially eligible to enter a
separate open-label study of LAI (Study INS-312), provided all entry criteria were met for
that study.

Inclusion Criteria:

1. 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

2. Be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis
and/or fibrocavitary disease by chest CT

3. Be willing to adhere to multi-drug treatment regimen during the course of the study

Exclusion Criteria:

1. Patients with cystic fibrosis

2. 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.

3. Active pulmonary tuberculosis requiring treatment at screening

4. History of lung transplantation

5. Prior exposure to LAI (including clinical study).
We found this trial at
61
sites
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
10147
mi
from 43215
Adelaide,
Click here to add this to my saved trials
513
mi
from 43215
Albany, NY
Click here to add this to my saved trials
1333
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
400
mi
from 43215
Allentown, PA
Click here to add this to my saved trials
378
mi
from 43215
Anderson, SC
Click here to add this to my saved trials
862
mi
from 43215
Bradenton, FL
Click here to add this to my saved trials
831
mi
from 43215
Brandon, FL
Click here to add this to my saved trials
809
mi
from 43215
Celebration, FL
Click here to add this to my saved trials
Charleston, South Carolina 29412
527
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
830
mi
from 43215
Clearwater, FL
Click here to add this to my saved trials
791
mi
from 43215
Clermont, FL
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
865
mi
from 43215
Columbia, SD
Click here to add this to my saved trials
6
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
679
mi
from 43215
Council Bluffs, IA
Click here to add this to my saved trials
430
mi
from 43215
Decatur, GA
Click here to add this to my saved trials
?
mi
from 43215
DeLand, FL
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
174
mi
from 43215
Farmington Hills, MI
Click here to add this to my saved trials
1993
mi
from 43215
Fresno, CA
Click here to add this to my saved trials
340
mi
from 43215
Gastonia, NC
Click here to add this to my saved trials
Huntersville, North Carolina 28078
336
mi
from 43215
Huntersville, NC
Click here to add this to my saved trials
668
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
810
mi
from 43215
Kissimmee, FL
Click here to add this to my saved trials
154
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
721
mi
from 43215
Lincoln, NE
Click here to add this to my saved trials
1975
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
425
mi
from 43215
Marietta, GA
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
335
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
496
mi
from 43215
Mineola, NY
Click here to add this to my saved trials
125
mi
from 43215
Muncie, IN
Click here to add this to my saved trials
798
mi
from 43215
Natchitoches, LA
Click here to add this to my saved trials
494
mi
from 43215
New Hyde Park, NY
Click here to add this to my saved trials
798
mi
from 43215
New Orleans, LA
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
682
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
792
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
Pittsfield, Massachusetts 01201
535
mi
from 43215
Pittsfield, MA
Click here to add this to my saved trials
888
mi
from 43215
Port Saint Lucie, FL
Click here to add this to my saved trials
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
1938
mi
from 43215
Poway, CA
Click here to add this to my saved trials
473
mi
from 43215
Ridgewood, NJ
Click here to add this to my saved trials
559
mi
from 43215
Rochester, MN
Click here to add this to my saved trials
365
mi
from 43215
Rock Hill, SC
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
San Juan Capistrano, California 92576
1956
mi
from 43215
San Juan Capistrano, CA
Click here to add this to my saved trials
866
mi
from 43215
Sebring, FL
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
349
mi
from 43215
Spartanburg, SC
Click here to add this to my saved trials
353
mi
from 43215
Springfield, IL
Click here to add this to my saved trials
2100
mi
from 43215
Stanford, CA
Click here to add this to my saved trials
831
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
862
mi
from 43215
Tyler, TX
Click here to add this to my saved trials
2018
mi
from 43215
Ventura, CA
Click here to add this to my saved trials
328
mi
from 43215
Washington,
Click here to add this to my saved trials
972
mi
from 43215
Weston, FL
Click here to add this to my saved trials
306
mi
from 43215
Winston-Salem, NC
Click here to add this to my saved trials
791
mi
from 43215
Winter Park, FL
Click here to add this to my saved trials