New inhaled drug aimed at stubborn lung infection shows promise, but trial halted early

NCT ID NCT06418711

Disease control Sponsor: Mannkind Corporation Source: ClinicalTrials.gov ↗

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

Summary

This phase 3 study tested an inhaled form of the antibiotic clofazimine added to standard therapy for people with MAC lung disease that did not respond to previous treatment. The goal was to see if the drug could clear the infection from sputum cultures and improve quality of life. The trial was terminated early, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: clofazimine inhalation suspension
What this could lead to: If successful, this could provide a new inhaled treatment option for people with hard-to-treat MAC lung infections, potentially improving infection clearance and quality of life.
What could go wrong: The trial was terminated early, so results are limited. Inhaled clofazimine may cause side effects like cough or breathing issues, and it is not yet proven to work better than standard care alone.

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

132 people

The number who actually took part.

Started

Sep 2024

Finished

Nov 2025

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 to 85 years

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: 1. Evidence of signed and dated informed consent document(s) indicating the participant has been informed of all pertinent aspects of the trial. 2. Age ≥18 years or legal age for the participating country (e.g., the legal age in South Korea is 19 years) and ≤85 years. 3. Evidence of underlying nodular bronchiectasis and/or fibrocavitary disease on a chest radiograph or chest computed tomography, as determined by the investigator, within the last 12 months. 4. MAC-positive culture results from at least two separates (at least 1 week apart) expectorated sputum samples, one taken within 12 months, and another taken within 3 months prior to the date of informed consent. Note: A sputum culture will be obtained at baseline, but the participant may be randomized prior to availability of the results. 5. Be able to produce at least 3 mL of sputum or be willing to undergo an induction that produces at least 3 mL of sputum for mycobacteriology. 6. FEV1 ≥40% of predicted during screening, as calculated by the local spirometry laboratory standards. 7. Currently receiving a multi-drug regimen of GBT for pulmonary NTM infection in line with the 2020 ATS/ERS/ESCMID/IDSA guideline for the treatment of NTM pulmonary disease for at least 6 months prior to consenting in this study, with no changes in this regimen within 2 months of screening. 8. For female participants of childbearing potential, a negative serum pregnancy test and agreement to use a protocol-recommended method of contraception during heterosexual intercourse from the start of the screening period until ≥12 months after the final dose of study therapy. Note: A female participant is considered to be of childbearing potential, i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 9. For male participants who can father a child and are having intercourse with females of childbearing potential, agreement to use a protocol-recommended method of contraception from the start of the study therapy until ≥12 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy. Note: A male participant is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. 10. Willingness and ability to comply with scheduled visits, drug inhalation plan, study procedures, laboratory tests, and study restrictions. Exclusion Criteria: 1. Cystic fibrosis. 2. Active tuberculosis. Note: Participants with a history of treated latent or active tuberculosis may be eligible as long as their sputum cultures in the last year are negative for tuberculosis and they are deemed by the investigator as not having current active tuberculosis. 3. Disseminated MAC or MABSC infection or participants with isolated MABSC infection. 4. Recent (i.e., within the last 3 months from date of screening) ICU admission with or without mechanical ventilation. 5. Inability to inhale with a nebulizer, in the opinion of the investigator. 6. Participants with known hypersensitivity to any of the ingredients or excipients of clofazimine. 7. Prior therapy with clofazimine in the previous 4 months from date of screening. 8. Participants with known resistance to clofazimine as treatment for MAC (i.e., MIC \>8 ug/mL for MAC). 9. Prior therapy with amikacin by any route of administration (e.g., inhaled or IV) in the previous 2 months from date of screening. 10. Ongoing participation in any other interventional drug or device clinical trial, or exposure to another investigational drug within 28 days prior to start of study treatment. Note: For investigational therapies that have a prolonged half-life, a case-by-case assessment will be made regarding the required washout period prior to being eligible for this study. 11. Current (or planned during the study) pregnancy or breastfeeding. 12. QT prolongation during screening (450 ms or longer), and/or uncontrolled sinus rhythm (\>110/minute). 13. Increased risk of proarrhythmia (e.g., recent \[within 6 months\] myocardial infarction, stroke, heart failure decompensation or left ventricular ejection of \<45%, ventricular arrhythmias, torsade de pointes, unstable angina, or high-degree atrioventricular block). 14. A family history of sudden cardiac death, unexplained death, long-QT syndrome, or death from a primary dysrhythmia potentially associated with QT prolongation. 15. Recent (within 6 months) initiation of or change in the dosing regimen of any concomitant medication that is known to prolong the QT interval. Note: Participants who are on a stable regimen, in the opinion of the investigator, of the concomitant medication during screening are eligible. 16. Chronic and clinically meaningful, in the opinion of the investigator, abnormalities in potassium, magnesium, or calcium levels. 17. Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 3 years before screening or anticipated during the study period. 18. Current alcohol, medication, or illicit drug abuse. 19. Prior or ongoing social or medical condition (e.g., concomitant illness, psychiatric condition, behavioral disorder), medical history, physical findings, ECG findings or laboratory abnormality that, in the opinion of the investigator, could adversely affect the safety of the participant, makes it unlikely that the course treatment or follow-up would be completed, or could impair the assessment of study results. 20. Any prior use of bedaquiline within 1 year of screening. 21. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5 times upper limit of normal (ULN) or total bilirubin \>1.5 times ULN during screening. 22. Absolute neutrophil count \<500/µL during screening. 23. Use of prednisone ≥10mg/day within 3 months prior to screening, or other significant immunosuppression as deemed by the investigator. 24. Estimated glomerular filtration rate \<30mL/minute/1.73 m2 (according to the CKD-EPI 2021 creatine equation) during screening. 25. Advanced liver disease (Child-Pugh Class A, B, or C).

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Conditions

The condition(s) this trial relates to.

Actinomycetales infectious disease Bacterial Infections and Mycoses bacterial infectious disease bronchiectasis gram-positive bacterial infections Infections lung disorder mycobacterial infectious disease Mycobacterium avium complex disease Mycobacterium Infections, Nontuberculous pulmonary non-tuberculous mycobacterial infection respiratory system disorder respiratory tract infectious disorder

As listed by the trial registrant

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

Mac lung disease Mycobacterium infections, nontuberculous Treatment refractory mac lung disease

Contacts and locations

Locations

Alfred Health

Melbourne, Victoria, 3004, Australia
AnMed Health

Anderson, South Carolina, 29621, United States
Asan Medical Center

Seoul, 05505, South Korea
Aso Iizuka Hospital

Fukuoka, 811-3195, Japan
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Center Hospital of the National Center for Global Health and Medicine

Tokyo, 162-8655, Japan
Chonnam National University Hospital

Gwangju, 61469, South Korea
Cleveland Clinic

Weston, Florida, 33331, United States
Columbia University

New York, New York, 10032, United States
Concord Repatriation General Hospital

Concord, Australia
Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Emory University School Of Medicine

Atlanta, Georgia, 30342, United States
Flourish Research

Winter Park, Florida, 32789, United States
Fukuoka University Chikushi Hospital

Fukuoka, 818-8502, Japan
Fukuoka University Hospital

Fukuoka, 814-0180, Japan
Gallipoli Medical Research Foundation

Greenslopes, Queensland, 4064, Australia
Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Himeji Medical Center

Hyōgo, 670-8520, Japan
Hoag Hospital

Newport Beach, California, 92663, United States
Ibarakihigashi National Hospital

Ibaraki, 319-1113, Japan
Infectious Disease Consultants Clinical Research

Wichita, Kansas, 67211, United States
Japan Anti-Tuberculosis Association Fukujuji Hospital

Tokyo, 204-8522, Japan
Japanese Red Cross Musashino Hospital

Tokyo, 180-8610, Japan
Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States
Kameda Clinic

Kamogawa-shi, 296-0041, Japan
Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan
Keio University Hospital

Shinjuku-ku, 160-8582, Japan
Low Country Infectious Diseases

Charleston, South Carolina, 29414, United States
Macquarie University Clinical Trials Unit

Sydney, New South Wales, 2109, Australia
Malcolm Randall Veterans Affairs Medical Center

Gainesville, Florida, 32608, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Matsusaka Municipal Hospital

Matsusaka, 515-8544, Japan
Mayo Clinic

Rochester, Minnesota, 55905, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Medster Research

Valdosta, Georgia, 31605, United States
Midway Specialty Care Center

West Palm Beach, Florida, 33401, United States
Minami Kyoto Hospital

Kyoto, 610-0113, Japan
Monash University Centre for Inflammatory Diseases

Cranbourne, Victoria, 3977, Australia
Montefiore Medical Center

The Bronx, New York, 10467, United States
Mount Sinai-National Jewish Respiratory Institute

New York, New York, 10029, United States
Mutual Aid Associations Toranomon Hospital

Tokyo, 105-8470, Japan
NYC Health and Hospitals-Elmhurst

Queens, New York, 11373, United States
NYU Langone Health

New York, New York, 10016, United States
National Hospital Organization - Osaka Toneyama Medical Center

Osaka, 560-8552, Japan
National Hospital Organization Fukuokahigashi Medical Center

Fukuoka, 811-3195, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai, 591-8555, Japan
National Hospital Organization Omuta National Hospital

Fukuoka, 837-0911, Japan
National Hospital Organization Shibukawa Medical Center

Gunma, 377-0280, Japan
National Hospital Organization Tenryu Hospital

Shizuoka, 434-8511, Japan
National Jewish Health

Denver, Colorado, 80206, United States
National Taiwan University Hospital

Hsinchu, 300, Taiwan
National Taiwan University Hospital

Taipei, Taiwan
Nishiniigata Chuo Hospital

Niigata, 945-8585, Japan
North Texas Infectious Diseases Consultants

Dallas, Texas, 75246, United States
Northwell Health

New Hyde Park, New York, 11042, United States
Ochsner Clinic Foundation

New Orleans, Louisiana, 70115, United States
Oregon Health & Science University

Portland, Oregon, 97239, United States
Reading Hospital

West Reading, Pennsylvania, 19611, United States
Royal Adelaide Hospital

Adelaide, 5000, Australia
Royal Perth Hospital Respiratory Clinic

Perth, Western Australia, 6000, Australia
Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States
SHOWA University Fujigaoka Hospital

Kanagawa, 227-8501, Japan
SHOWA University Northern Yokohama Hospital

Yokohama, 224-8503, Japan
Saitama Prefectural Cardiovascular and Respiratory Center

Saitama, 180-8610, Japan
Samsung Medical Center

Seoul, 06351, South Korea
Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States
Sendai Kousei Hospital

Miyagi, 980-0873, Japan
Seoul National University Hospital

Seoul, 03080, South Korea
Severance Hospital

Seoul, 03722, South Korea
St. Francis Sleep, Allergy & Lung Institute

Clearwater, Florida, 33765, United States
Stanford University

Stanford, California, 94305, United States
Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia
Taichung Veterans General Hospital

Taichung, 407219, Taiwan
Taipei Veterans General Hospital

Taipei, 112, Taiwan
Temple Lung Center

Philadelphia, Pennsylvania, 19140, United States
The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, 06591, South Korea
The George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States
The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia
The University of Texas Health Science Center

Tyler, Texas, 75708, United States
Theia Clinical Research

St. Petersburg, Florida, 33707, United States
Toho University Omori Medical Center

Tokyo, 143-8541, Japan
UCONN Health

Farmington, Connecticut, 06030-1225, United States
UVA Health Infectious Diseases Clinic

Charlottesville, Virginia, 22903, United States
University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, 35294, United States
University of California Davis Medical Center

Sacramento, California, 95817, United States
University of California San Francisco

San Francisco, California, 94143, United States
University of California San Francisco Fresno

Fresno, California, 93701, United States
University of Florida College of Medicine

Jacksonville, Florida, 32209, United States
University of Hawaii

Honolulu, Hawaii, 96813, United States
University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Missouri

Columbia, Missouri, 65201, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7248, United States
University of South Florida

Tampa, Florida, 33620, United States
VA Bay Pines

Bay Pines, Florida, 33744, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Yale University

New Haven, Connecticut, 06520-8057, United States

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