Study on the Effects of Amikacin Liposome Inhalation, Azithromycin, and Ethambutol in Adults with Newly Diagnosed Nontuberculous Mycobacterial Lung Infection

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What is this study about?

This clinical trial is focused on studying a lung infection known as nontuberculous mycobacterial (NTM) lung infection, specifically caused by a group of bacteria called Mycobacterium avium Complex (MAC). The study is testing a treatment that includes a medication called Amikacin Liposome Inhalation Suspension (ALIS), which is inhaled, along with other medications taken by mouth, such as azithromycin and ethambutol. The purpose of the study is to evaluate how effective this combination of treatments is in improving respiratory symptoms in patients with this type of lung infection.

Participants in the study will receive either the ALIS treatment combined with azithromycin and ethambutol or a placebo, which is a substance with no active medication, combined with azithromycin and ethambutol. The study will last for about 13 months, during which time participants will be monitored for changes in their respiratory symptoms and overall health. The study aims to see if the ALIS-based treatment can help reduce symptoms and improve the quality of life for those with this lung infection.

Throughout the study, participants will have regular check-ups and tests to assess their health and the effectiveness of the treatment. These tests may include providing sputum samples, which are samples of mucus from the lungs, and undergoing imaging tests like computed tomography (CT) scans to look at the lungs. The study will also track any side effects or changes in symptoms to ensure the safety and well-being of the participants.

1 enrollment

Upon joining the study, the patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and a positive sputum culture for Mycobacterium avium Complex (MAC) within the last six months.

A chest CT scan may be required if not performed within the last six months to assess lung condition.

2 treatment initiation

The patient will begin treatment with a regimen that includes Amikacin Liposome Inhalation Suspension (ALIS), Azithromycin, and Ethambutol. The ALIS is administered via inhalation, while Azithromycin and Ethambutol are taken orally.

The specific dosages are as follows: Azithromycin 250 mg film-coated tablets and Ethambutol 100 mg or 400 mg tablets. The frequency and duration of administration will be determined by the study protocol.

3 ongoing treatment and monitoring

Throughout the study, the patient will continue the prescribed treatment regimen. Regular monitoring will occur to assess the effectiveness and safety of the treatment.

The patient will be required to provide sputum samples periodically to evaluate the presence of MAC and to monitor any changes in respiratory symptoms.

4 evaluation at month 13

At month 13, the primary evaluation will focus on changes in respiratory symptoms compared to the baseline.

Secondary evaluations will include assessments of fatigue symptoms and the proportion of patients achieving culture conversion, which means having negative cultures for MAC.

5 final assessment

The study will conclude with a final assessment to determine the overall efficacy and safety of the treatment regimen.

The patient will undergo a comprehensive review of their health status, including any side effects experienced during the study.

Who Can Join the Study?

Must be a male or female who is at least 18 years old. In South Korea, you must be 19 or older, and in Japan, 20 or older.
Must currently have a diagnosis of a MAC lung infection. This means an infection in the lungs caused by a specific type of bacteria called Mycobacterium avium Complex.
Must have a positive sputum culture for MAC within 6 months before the screening. A sputum culture is a test to find bacteria in the mucus you cough up from your lungs.
Must have a positive sputum culture for MAC at the time of screening.
Must have had a chest CT scan within 6 months before screening to check for lung cavities. If not, a new chest CT scan will be needed during screening. A CT scan is an imaging test that helps doctors see inside your body.
Must have respiratory signs or symptoms at screening that the doctor believes are due to the current MAC lung infection.
Must have an average QOL-B Respiratory domain score of 85 or less at screening and on the day of enrollment. This score measures the impact of respiratory symptoms on your quality of life.
Must have any underlying lung disease, like COPD or bronchiectasis, managed according to the best local standard of care and be on stable treatment for at least 4 weeks before joining the study. COPD is a lung disease that makes it hard to breathe, and bronchiectasis is a condition where the airways in the lungs are damaged.
Must be willing and able to follow the study treatment plan during the study.
Must be able to produce about 2 mL of sputum for testing at screening, either naturally or with help.
Women who can have children and men who are fertile must agree to use a highly effective method of birth control from the start of the study to at least 90 days after the last dose. Examples include abstinence, copper IUD, hormonal methods, exclusive homosexual relationship, or a male partner who has had a surgical procedure to prevent having children.
Must provide signed informed consent before taking any study drugs or undergoing any study-related procedures. This means you agree to participate in the study after understanding all the details.
Must be able to follow the study drug use, attend study visits, and complete study procedures as outlined in the study plan.
Men with partners who can have children must agree to use condoms, and their partners should use a highly effective method of birth control if not pregnant.

Who Cannot Join the Study?

Patients who have a different type of lung infection that is not caused by Mycobacterium avium Complex (MAC). This is a specific type of bacteria that can cause lung problems.
Patients who have already been treated for this specific lung infection before. The study is for those who are newly diagnosed.
Patients who are unable to use the inhalation method required for the study. This involves breathing in medication through a special device.
Patients with other serious health conditions that might interfere with the study. This could include severe heart, liver, or kidney problems.
Patients who are pregnant or breastfeeding. The study may not be safe for unborn babies or infants.
Patients who are currently participating in another clinical trial. Being in more than one study at a time can affect the results.
Patients who have allergies to the medications used in the study. This includes any known reactions to the drugs being tested.
Patients who have a history of substance abuse. This could affect their ability to follow the study procedures.
Patients who are unable to provide informed consent. This means they cannot fully understand or agree to the study requirements.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Augustinerinnen Krankenhaeuser gGmbH	Cologne	Germany
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Koranyi National Institute For Pulmonology	Budapest	Hungary
Lungenfachklinik	Immenhausen	Germany
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Hospital Foch	Suresnes	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Asklepios Klinik Gauting GmbH	Gauting	Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
CHU Saint Pierre	Brussels	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH	Berlin	Germany
Multimedica S.p.A.	Milan	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Ente Ospedaliero Ospedali Galliera Di Genova	Genoa	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Aalborg University Hospital	Aalborg	Denmark
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Saint Joseph	Marseille	France
Centre Hospitalier Universitaire De Nice	Nice	France
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Hospital Alvaro Cunqueiro	Vigo	Spain
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Uzxnellcnq Hjcwhfmjl Pgtzq Ssmmeffxkcz Cxhgrxq Fkxi	Paris	France
Lrkrimalsyh aa Rrarhttevlzvl	Lungenärzte am Rundfunkplatz	Germany
Ladot Goubysg Huxwpozu Oe Avrvir	Athens	Greece
Akinmz Useujfmynj Hmxfbail	Aarhus	Denmark
Aymuxia Uvp Ittzr Dr Rmnwtp Eozqyw	Reggio Emilia	Italy
Fsysbpies Piyx Lx Inqyeoupyfqoc Brolwcnjn Dyq Hnpcamlt Ugdbggdxccaot Lw Pxs	Madrid	Spain
Iqedqzxwligu Sgqhzpfrrsseags Pbootbia Lqqtqqcc lqge Kmpefvslh Lim	Kielce	Poland
Jfoojpvi Kqprut Upiuownnzb	Linz	Austria
Hebpgtdq Vyaq drnssfkv	Barcelona	Spain
Hfutpjbr Uqvqpfdxkrzrac Sqcbmtxiwb &sqgnbg Hnpdxai db Hhqbljpdszb	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	15.10.2020
Belgium	Not recruiting	15.10.2020
Denmark	Not recruiting	15.10.2020
France	Not recruiting	15.10.2020
Germany	Not recruiting	15.10.2020
Greece	Not recruiting	15.10.2020
Hungary	Not recruiting	15.10.2020
Italy	Not recruiting	15.10.2020
Poland	Not recruiting	15.10.2020
Portugal	Not recruiting	15.10.2020
Spain	Not recruiting	15.10.2020

Trial locations

Investigated drugs:

Amikacin Liposome Inhalation Suspension (ALIS) is a medication used in this trial to treat lung infections caused by a specific type of bacteria known as Mycobacterium avium Complex (MAC). It is administered through inhalation, allowing the medication to directly reach the lungs where the infection is located. This form of amikacin is encapsulated in liposomes, which are tiny fat-like particles that help deliver the drug more effectively to the site of infection.

Azithromycin (AZI) is an antibiotic that is part of the background regimen in this study. It is used to help fight the bacterial infection in the lungs. Azithromycin works by stopping the growth of bacteria, making it easier for the body to eliminate the infection.

Ethambutol (ETH) is another antibiotic included in the background regimen. It is used alongside other medications to treat lung infections caused by Mycobacterium avium Complex (MAC). Ethambutol works by inhibiting the growth of bacteria, helping to control and reduce the infection in the lungs.

Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium avium Complex – This disease is a type of lung infection caused by a group of bacteria known as Mycobacterium avium complex (MAC). It primarily affects individuals with underlying lung conditions or weakened immune systems. The infection leads to symptoms such as chronic cough, fatigue, and weight loss. Over time, it can cause progressive lung damage and respiratory issues. The bacteria are commonly found in the environment, including water and soil, and are inhaled into the lungs. The disease progresses slowly, often requiring long-term management to control symptoms and prevent further lung damage.

Trial ID:

2023-505273-33-00

Protocol code:

INS-416

NCT ID:

NCT04677569

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Amikacin Liposome Inhalation, Azithromycin, and Ethambutol in Adults with Newly Diagnosed Nontuberculous Mycobacterial Lung Infection

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?