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
938
mi
from
Gastonia, NC
Click here to add this to my saved trials
9338
mi
from
Adelaide,
Click here to add this to my saved trials
1306
mi
from
Albany, NY
Click here to add this to my saved trials
523
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1209
mi
from
Allentown, PA
Click here to add this to my saved trials
874
mi
from
Anderson, SC
Click here to add this to my saved trials
1132
mi
from
Bradenton, FL
Click here to add this to my saved trials
1123
mi
from
Brandon, FL
Click here to add this to my saved trials
1143
mi
from
Celebration, FL
Click here to add this to my saved trials
Charleston, South Carolina 29412
1064
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
959
mi
from
Charlotte, NC
Click here to add this to my saved trials
1102
mi
from
Clearwater, FL
Click here to add this to my saved trials
1122
mi
from
Clermont, FL
Click here to add this to my saved trials
895
mi
from
Cleveland, OH
Click here to add this to my saved trials
543
mi
from
Columbia, SD
Click here to add this to my saved trials
810
mi
from
Columbus, OH
Click here to add this to my saved trials
263
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
805
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
DeLand, FL
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
829
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
1210
mi
from
Fresno, CA
Click here to add this to my saved trials
Huntersville, North Carolina 28078
954
mi
from
Huntersville, NC
Click here to add this to my saved trials
1053
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1149
mi
from
Kissimmee, FL
Click here to add this to my saved trials
725
mi
from
Lexington, KY
Click here to add this to my saved trials
219
mi
from
Lincoln, NE
Click here to add this to my saved trials
1171
mi
from
Long Beach, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
788
mi
from
Marietta, GA
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
630
mi
from
Milwaukee, WI
Click here to add this to my saved trials
1306
mi
from
Mineola, NY
Click here to add this to my saved trials
688
mi
from
Muncie, IN
Click here to add this to my saved trials
493
mi
from
Natchitoches, LA
Click here to add this to my saved trials
1303
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
697
mi
from
New Orleans, LA
Click here to add this to my saved trials
1290
mi
from
New York, NY
Click here to add this to my saved trials
262
mi
from
Omaha, NE
Click here to add this to my saved trials
1139
mi
from
Orlando, FL
Click here to add this to my saved trials
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
853
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsfield, Massachusetts 01201
1333
mi
from
Pittsfield, MA
Click here to add this to my saved trials
1244
mi
from
Port Saint Lucie, FL
Click here to add this to my saved trials
1383
mi
from
Portland, OR
Click here to add this to my saved trials
1129
mi
from
Poway, CA
Click here to add this to my saved trials
1281
mi
from
Ridgewood, NJ
Click here to add this to my saved trials
515
mi
from
Rochester, MN
Click here to add this to my saved trials
953
mi
from
Rock Hill, SC
Click here to add this to my saved trials
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
San Juan Capistrano, California 92576
1149
mi
from
San Juan Capistrano, CA
Click here to add this to my saved trials
1184
mi
from
Sebring, FL
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
901
mi
from
Spartanburg, SC
Click here to add this to my saved trials
460
mi
from
Springfield, IL
Click here to add this to my saved trials
1329
mi
from
Stanford, CA
Click here to add this to my saved trials
1117
mi
from
Tampa, FL
Click here to add this to my saved trials
398
mi
from
Tyler, TX
Click here to add this to my saved trials
1217
mi
from
Ventura, CA
Click here to add this to my saved trials
1127
mi
from
Washington,
Click here to add this to my saved trials
1299
mi
from
Weston, FL
Click here to add this to my saved trials
976
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
1140
mi
from
Winter Park, FL
Click here to add this to my saved trials