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Inhaled antibiotic shows promise against stubborn lung infection

NCT ID NCT04677569

Disease control Sponsor: Insmed Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding an inhaled antibiotic (ALIS) to standard oral antibiotics helps adults with a new diagnosis of a hard-to-treat lung infection caused by MAC bacteria. About 425 adults took part. The main goal was to see if the combination improved breathing symptoms after 13 months compared to a placebo plus standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

425 people

The number who actually took part.

Started

Apr 2021

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, ≥ 18 years of age (19 years or older in South Korea, 20 years or older in Japan). * Current diagnosis of MAC lung infection. MAC or mixed infection with MAC as the dominant species is allowed, with MAC as the intended organism for treatment. * A chest computerized tomography (CT) scan, read locally, within 6 months prior to Screening to determine presence and size of pulmonary cavities. Participants who do not have a chest CT scan within 6 months prior to Screening will be required to obtain a chest CT scan, read locally, during Screening. * Willingness and ability to adhere to prescribed study treatment during the study. * Women of childbearing potential (WOCBP) (ie, fertile following menarche and until becoming postmenopausal unless permanently sterile) and fertile men (ie, all men after puberty unless permanently sterile by bilateral orchidectomy) agree to practice a highly effective method of birth control from Day 1 to at least 90 days after the last dose. Examples of such birth controls are: * true abstinence (refraining from heterosexual intercourse during the entire study), * copper intrauterine device (IUD), * hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill \[combined with barrier method\]), * exclusive homosexual relationship, or * sole male partner who has undergone surgical sterilization with confirmation of azoospermia at least 3 months post procedure. * Provide signed informed consent prior to administration of study drugs or performing any study-related procedure. * Be able to comply with study drugs use, study visits, and study procedures as defined by the protocol. * Men with partners who are WOCBP (pregnant or non-pregnant) agree to use condoms and non-pregnant partners should practice a highly effective method of birth control Exclusion Criteria: * Diagnosis of cystic fibrosis (CF). * History of more than 3 MAC lung infections (a 4th MAC lung infection is not eligible) * Received any mycobacterial antibiotic treatment for current MAC lung infection * Refractory MAC lung infection, defined as having positive MAC cultures while being treated with a multidrug mycobacterial antibiotic treatment regimen for a minimum of 6 consecutive months and no documented successful treatment, defined as negative sputum culture for MAC and cessation of treatment * Relapse of prior MAC lung infection, defined as positive sputum culture for MAC ≤6 months of cessation of prior successful treatment * Evidence of any pulmonary cavity ≥ 2 cm in diameter, as determined by chest CT scan, read locally, during Screening or within 6 months prior to Screening * Radiographic finding of new lobar consolidation, atelectasis, significant pleural effusion, or pneumothorax during routine clinical care within 2 months prior to Screening * Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year prior to Screening or anticipated during the study * Acute pulmonary exacerbation (eg, chronic obstructive pulmonary disease (COPD) or bronchiectasis) requiring treatment with antibiotics, or corticosteroids (intravenous \[IV\] or oral), within 4 weeks prior to and during Screening * Current smoker * History of lung transplantation * Prior exposure to ALIS (including clinical study) * Known hypersensitivity or contraindications to use to ALIS, aminoglycosides, or any of their excipients * Disseminated MAC infection * Administration of any investigational drug within 8 weeks prior to Screening * Known or suspected acquired immunodeficiency syndromes (Human Immunodeficiency Virus (HIV) -positive, regardless of CD4 counts). Other immunodeficiency syndromes that may interfere with study participation in the opinion of the Investigator * Current alcohol, medication, or illicit drug abuse * Known and active COVID-19 infection * Known hypersensitivity or contraindications to use of ethambutol, azithromycin (including other macrolides or ketolides), or any of their excipients per local labeling guidance.

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Conditions

The condition(s) this trial relates to.

mycobacterial infectious disease Mycobacterium avium complex disease Mycobacterium Infections, Nontuberculous

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mycobacterium infections, nontuberculous

Contacts and locations

Locations

  • ARG001

    Rosario, Santa Fe Province, S2000DTC, Argentina

  • ARG002

    Córdoba, CArdoba, 5000, Argentina

  • ARG003

    CArdoba, CArdoba, X5003DCE, Argentina

  • ARG004

    Ciudad autAnoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

  • ARG005

    Quilmes, Buenos Aires, B1878FNR, Argentina

  • ARG006

    Villa Vatteone, Buenos Aires, B1853AIK, Argentina

  • ARG007

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • AUS001

    South Brisbane, Queensland, 4101, Australia

  • AUS002

    Westmead, New South Wales, 2145, Australia

  • AUS003

    Greenslopes, Queensland, 4120, Australia

  • AUS004

    New Lambton Heights, New South Wales, 2305, Australia

  • AUS005

    Perth, 5000, Australia

  • AUS006

    Concord, New South Wales, 2139, Australia

  • AUS007

    Clayton, Victoria, 3168, Australia

  • AUS008

    Adelaide, South Australia, 5000, Australia

  • AUS009

    Melbourne, Victoria, 3001, Australia

  • AUS010

    Chermside, Queensland, 4032, Australia

  • AUS011

    Woolloongabba, Queensland, 4102, Australia

  • AUS012

    Birtinya, Queensland, 4575, Australia

  • AUS013

    Douglas, Queensland, 4814, Australia

  • AUS014

    Meadowbrook, Queensland, 4131, Australia

  • AUS015

    Spearwood, Western Australia, 6163, Australia

  • AUS016

    Herston, Queensland, 4029, Australia

  • AUT001

    Linz, Upper Austria, 4040, Austria

  • AUT003

    Wels, OberAsterreich, 4600, Austria

  • BEL001

    Leuven, 3000, Belgium

  • BEL002

    Ghent, 9000, Belgium

  • BEL003

    Brussels, Brussels Capital, 1000, Belgium

  • CAN002

    Toronto, Ontario, M5T 2S8, Canada

  • CAN003

    Winnepeg, Manitoba, R2H 2A6, Canada

  • CAN004

    Windsor, Ontario, N8X-5A6, Canada

  • CHL001

    Curicó, Maule Region, 3440000, Chile

  • CHL002

    Quillota, 2260000, Chile

  • CHL003

    Valparaíso, 2340000, Chile

  • CHL004

    Talca, Chile

  • DNK001

    Roskilde, Region Sjælland, 4000, Denmark

  • DNK002

    Aarhus N, 8200, Denmark

  • DNK003

    Odensa C, 5000, Denmark

  • DNK004

    Aalborg, 9000, Denmark

  • DNK005

    Vejle, Region Syddanmark, 7100, Denmark

  • ESP001

    Madrid, 28034, Spain

  • ESP002

    Barcelona, 08003, Spain

  • ESP003

    Barcelona, 8035, Spain

  • ESP004

    Madrid, 28046, Spain

  • ESP005

    Girona, 17007, Spain

  • ESP006

    Pontevedra, 36001, Spain

  • ESP007

    Vigo, Pontevedra, 36312, Spain

  • ESP008

    Barcelona, 8025, Spain

  • ESP009

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • ESP010

    Madrid, 28007, Spain

  • ESP011

    Pamplona, 31008, Spain

  • ESP012

    Seville, 41013, Spain

  • FRA001

    Marseille, 13285, France

  • FRA002

    Créteil, 94000, France

  • FRA003

    Saint-Pierre, 97448, France

  • FRA004

    Saint-Denis, 97405, France

  • FRA005

    Brest, 29609, France

  • FRA006

    Amiens, 80054, France

  • FRA007

    Caen, 14033, France

  • FRA008

    Nantes, Loire-Atlantique, 44000, France

  • FRA009

    Paris, 75018, France

  • FRA010

    Suresnes, Hauts-de-Seine, 92151, France

  • FRA011

    Toulouse, 31400, France

  • FRA012

    Nice, Alpes-Maritimes, 6000, France

  • FRA013

    Paris, 75020, France

  • FRA014

    Paris, 75013, France

  • FRA015

    Pessac, Gironde, 33064, France

  • FRA016

    Strasbourg, Bas-Rhin, 67091, France

  • GBR001

    Cambridge, CB2 OAY, United Kingdom

  • GBR002

    Dundee, DD1 9SY, United Kingdom

  • GBR003

    London, SW3 6NP, United Kingdom

  • GBR004

    Liverpool, L14 3PE, United Kingdom

  • GBR005

    Aberdeen, AB25 2ZN, United Kingdom

  • GBR007

    London, EC1A 7BE, United Kingdom

  • GBR008

    Birmingham, West Midlands, B9 5SS, United Kingdom

  • GBR009

    Plymouth, Devon, PL6 8BQ, United Kingdom

  • GBR010

    London, NW32QG, United Kingdom

  • GBR012

    Salford, Lancashire, M6 8HD, United Kingdom

  • GBR013

    Swansea, West Glamorgan, SA6 6NL, United Kingdom

  • GER001

    Donaustauf, Bavaria, 93093, Germany

  • GER002

    Frankfurt, 69590, Germany

  • GER003

    Borstel, Lower Saxony, 23845, Germany

  • GER004

    Freiburg im Breisgau, 79106, Germany

  • GER005

    München, Bavaria, 80335, Germany

  • GER006

    Dresden, 1307, Germany

  • GER007

    Hanover, 30625, Germany

  • GER008

    Berlin, 13125, Germany

  • GER009

    Essen, 45127, Germany

  • GER010

    Immenhausen, Hesse, 34376, Germany

  • GER011

    Cologne, North Rhine-Westphalia, 51109, Germany

  • GER012

    Potsdam, Brandenburg, 14467, Germany

  • GER013

    Gauting, Bavaria, 82131, Germany

  • GER014

    Cologne, North Rhine-Westphalia, 50678, Germany

  • GRC001

    Heraklion, 71110, Greece

  • GRC002

    Athens, Attica, 11527, Greece

  • GRC003

    Alexandroupoli, 681 00, Greece

  • HUN001

    Törökbálint, 2045, Hungary

  • HUN002

    Budapest, 1121, Hungary

  • ISR001

    Ashkelon, 78100, Israel

  • ISR002

    Beer-Yaakov, 70300, Israel

  • ISR003

    Petah Tikva, 4910000, Israel

  • ISR004

    Ramat Gan, 52621, Israel

  • ISR005

    Jerusalem, 91120, Israel

  • ISR007

    Haifa, 34362, Israel

  • ISR008

    Tel Aviv, Tel Aviv, 64239, Israel

  • ITA001

    Milan, 20122, Italy

  • ITA002

    Milan, Milano, 20162, Italy

  • ITA003

    Pavia, 27100, Italy

  • ITA004

    Florence, 50134, Italy

  • ITA005

    Roma, 00168, Italy

  • ITA006

    Modena, Emilia-Romagna, 41124, Italy

  • ITA007

    Monza, 20900, Italy

  • ITA008

    Siena, Tuscany, 53100, Italy

  • ITA009

    Milan, 20123, Italy

  • ITA010

    Genoa, Liguria, 16128, Italy

  • ITA011

    Reggio Emilia, Emilia-Romagna, 42123, Italy

  • JPN001

    Fukui, 910-8526, Japan

  • JPN002

    Sakaishi, 591-8555, Japan

  • JPN003

    Jonan-ku, Japan

  • JPN004

    Fukuoka, 819-8555, Japan

  • JPN005

    Tokyo, Japan

  • JPN006

    Nagano, 380-0928, Japan

  • JPN008

    Shinjuku-ku, Tokyo, 1628655, Japan

  • JPN009

    Shimonoseki, 750-8520, Japan

  • JPN010

    Kiyose, 204-8522, Japan

  • JPN011

    Nagoya, Aiti, 465-0065, Japan

  • JPN012

    Naka-gun, 319-1113, Japan

  • JPN014

    Hamamatsu, Shizuoka, 434-8511, Japan

  • JPN015

    Kiyose-Shi, Tokyo, 204-0023, Japan

  • JPN016

    Toyonaka-Shi, Ôsaka, 560-0045, Japan

  • JPN017

    Matsusaka-Shi, Mie-ken, 515-0073, Japan

  • JPN018

    Nagasaki, Nagasaki, 852-8501, Japan

  • JPN019

    Izumo-Shi, Shimane, 693-0021, Japan

  • JPN020

    Kita Kyushu-shi, Hukuoka, 807-8556, Japan

  • JPN021

    Ōta-ku, Tokyo, 143-8541, Japan

  • JPN022

    Yokohama-Shi Tsuzuki-Ku, Kanagawa, 224-0032, Japan

  • JPN023

    Kurashiki-Shi, Okayama-ken, 710-0052, Japan

  • KOR001

    Seoul, South Korea

  • KOR002

    Seoul, 05505, South Korea

  • KOR003

    Seoul, 06973, South Korea

  • KOR004

    Seoul, 03722, South Korea

  • KOR005

    Seongnam-si, Gyeonggido, 13620, South Korea

  • KOR006

    Incheon, 22332, South Korea

  • KOR007

    Seongbuk-Gu, Seoul Teugbyeolsi, 02841, South Korea

  • KOR008

    Ansan-si, Gyeonggido, 15355, South Korea

  • KOR009

    Seoul, 06591, South Korea

  • NZL001

    Christchurch, 8461, New Zealand

  • NZL002

    Hamilton, Waikato Region, 3204, New Zealand

  • NZL003

    Hastings, Hawkes's Bay, 4122, New Zealand

  • NZL004

    Auckland, 1051, New Zealand

  • POL003

    Kielce, Świętokrzyskie Voivodeship, 25-751, Poland

  • PRT002

    Braga, 4710-243, Portugal

  • PRT003

    Lisbon, 1796-001, Portugal

  • TUR002

    Kocaeli, 41380, Turkey (Türkiye)

  • TUR003

    Izmir, 35110, Turkey (Türkiye)

  • TUR004

    Maltepe, Istanbul, 34844, Turkey (Türkiye)

  • TWN001

    Douliu, 640, Taiwan

  • TWN002

    Taipei, 116, Taiwan

  • TWN003

    Kaohsiung City, 813, Taiwan

  • TWN004

    Chiayi City, Chiayi, 613, Taiwan

  • TWN005

    Kaohsiung City, 807, Taiwan

  • TWN006

    Taipei, 10002, Taiwan

  • TWN007

    New Taipei City, 23561, Taiwan

  • TWN008

    Taipei, 11217, Taiwan

  • TWN009

    Taipei, 11490, Taiwan

  • TWN010

    Taipei, 110, Taiwan

  • TWN011

    Taipei, 10002, Taiwan

  • TWN012

    Hsinchu, 300, Taiwan

  • USA001

    Denver, Colorado, 80206, United States

  • USA002

    New Orleans, Louisiana, 70112, United States

  • USA003

    Clearwater, Florida, 33765, United States

  • USA004

    Lawrenceville, Georgia, 30046-3325, United States

  • USA006

    San Antonio, Texas, 78258, United States

  • USA007

    Winston-Salem, North Carolina, 27103, United States

  • USA008

    Birmingham, Alabama, 35233-1711, United States

  • USA009

    Omaha, Nebraska, 68198, United States

  • USA011

    New York, New York, 10017, United States

  • USA012

    Rock Hill, South Carolina, 29732, United States

  • USA013

    Rochester, Minnesota, 55905, United States

  • USA014

    St. Petersburg, Florida, 33707, United States

  • USA015

    DuBois, Pennsylvania, 15801, United States

  • USA016

    Dallas, Texas, 75246, United States

  • USA017

    Baltimore, Maryland, 21224-3057, United States

  • USA018

    Cleveland, Ohio, 44195, United States

  • USA019

    Leesburg, Florida, 34748, United States

  • USA020

    Charleston, South Carolina, 29425, United States

  • USA021

    McKinney, Texas, 75069-8085, United States

  • USA022

    Franklin, Tennessee, 37067, United States

  • USA023

    Washington D.C., District of Columbia, 20007, United States

  • USA024

    Charleston, South Carolina, 29414, United States

  • USA025

    Portland, Oregon, 97239, United States

  • USA026

    Sebring, Florida, 33870, United States

  • USA028

    Brandon, Florida, 33511-5719, United States

  • USA029

    Rincon, Georgia, 31326, United States

  • USA030

    Springfield, Illinois, 62702, United States

  • USA031

    Chicago, Illinois, 60611, United States

  • USA032

    Toms River, New Jersey, 08755-8000, United States

  • USA033

    Charlotte, North Carolina, 28277-8915, United States

  • USA034

    Mooresville, North Carolina, 28117, United States

  • USA035

    Charlotte, North Carolina, 28273, United States

  • USA037

    Kansas City, Kansas, 66160, United States

  • USA038

    Atlanta, Georgia, 30342-2147, United States

  • USA039

    Naples, Florida, 34102-5444, United States

  • USA040

    Philadelphia, Pennsylvania, 19104, United States

  • USA041

    Hendersonville, Tennessee, 37075, United States

  • USA042

    Kissimmee, Florida, 34746, United States

  • USA043

    Jacksonville, Florida, 32204, United States

  • USA044

    Anderson, South Carolina, 29621, United States

  • USA045

    Omaha, Nebraska, 68124, United States

  • USA046

    New Port Richey, Florida, 34652, United States

  • USA047

    Jacksonville, Florida, 32224, United States

  • USA048

    San Diego, California, 92103, United States

  • USA050

    Stanford, California, 94305, United States

  • USA051

    Durham, North Carolina, 27710-0001, United States

  • USA052

    Tyler, Texas, 75708, United States

  • USA053

    Weston, Florida, 33331, United States

  • USA054

    Sarasota, Florida, 34239-2913, United States

  • USA055

    Santa Barbara, California, 93105, United States

  • USA058

    Sacramento, California, 95817, United States

  • USA059

    The Bronx, New York, 10461, United States

  • USA060

    Los Angeles, California, 90033-5313, United States

  • USA061

    St Louis, Missouri, 63110, United States

  • USA062

    Fresno, California, 93701, United States

  • USA063

    Columbus, Ohio, 43210-1240, United States

  • USA064

    Cincinnati, Ohio, 45267, United States

  • USA065

    Bayside, New York, 11361, United States

  • USA066

    Augusta, Georgia, 30912, United States

  • USA067

    Tampa, Florida, 33606, United States

  • USA068

    Tampa, Florida, 33614-7101, United States

  • USA069

    Hillsborough, New Jersey, 08844, United States

  • USA070

    St. Petersburg, Florida, 33704-2733, United States

  • USA071

    Portland, Oregon, 97213-2982, United States

  • USA072

    Jacksonville, Florida, 32207-8567, United States

  • USA073

    Springfield, Illinois, 62702-4968, United States

  • USA074

    Iowa City, Iowa, 52242-1081, United States

  • USA075

    Cincinnati, Ohio, 45242-4402, United States

  • USA076

    Charlotte, North Carolina, 28204, United States

  • USA077

    Springfield, Massachusetts, 01107, United States

  • USA078

    Nashville, Tennessee, 37232, United States

  • USA079

    Coeur d'Alene, Idaho, 83814, United States

  • USA080

    Bradenton, Florida, 34209, United States

  • USA081

    San Francisco, California, 94143, United States

  • USA082

    Columbia, Missouri, 65212-1000, United States

  • USA083

    Charlottesville, Virginia, 22903, United States

  • USA084

    Sebastian, Florida, 32958, United States

  • USA085

    Jacksonville, Florida, 32209-6511, United States

  • USA086

    Houston, Texas, 77070-1190, United States

  • USA087

    Madison, Wisconsin, 53792-0001, United States

  • USA088

    East Syracuse, New York, 13057, United States

  • USA089

    Temple, Texas, 76508, United States

  • USA090

    Newport Beach, California, 92663, United States

  • USA091

    Denison, Texas, 75020, United States

  • USA092

    Providence, Rhode Island, 02906, United States

  • USA093

    Philadelphia, Pennsylvania, 19107, United States

  • USA096

    Naples, Florida, 34102, United States

  • USA097

    Naples, Florida, 34102, United States

  • USA099

    Lexington, Massachusetts, 02421, United States

  • USA100

    Dallas, Texas, 75246, United States

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