Summary:
CONVERT is a clinical research study designed to evaluate an investigational medication—Liposomal Amikacin for Inhalation (LAI)—in adult patients with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium avium Complex (MAC), who have not experienced success with previous treatments. The CONVERT study will take place in approximately 150 locations in North America, Europe, Asia-Pacific, and Australia.
What is the purpose of the CONVERT study?
The CONVERT study has the following main goals, in addition to determining the safety of the study medication:
- To determine if and how well the study medication works, when taken once daily in addition to your current oral medicine at
- achieving 3 lab tests in a row that do not show MAC (the germ that causes your lung infection)
- increasing the distance you can walk in a 6-minute period
- maintaining lab tests that do not show MAC during the follow-up phase when the entire course of treatment has been completed
What is NTM?
Nontuberculous Mycobacteria (NTM) is a naturally occurring pathogen widely found in the environment, including soil and tap water. In most people, exposure to NTM does not lead to infection. However, patients with structural lung disease, such as bronchiectasis, COPD, cystic fibrosis (CF), and asthma are at greater risk of developing NTM lung infections. With possible symptoms—similar to other lung infections—ranging from persistent cough and shortness of breath to a profound sense of fatigue, diagnosing NTM can be difficult. The Mycobacterium avium Complex (MAC) is one of the most frequently
identified species in NTM infections and accounts for more than 80% of all NTM infections.
What is the investigational medication?
Liposomal Amikacin for Inhalation (LAI) is an investigational drug comprising the antibiotic amikacin in Insmed’s proprietary liposomal technology formulation. LAI is being investigated for treatment of serious lung infections such as those caused by NTM, through delivery of antibiotic directly to the site of the lung infection.
Who is the study sponsor?
This study has been developed and sponsored by Insmed Incorporated, a biotechnology company dedicated to development of novel, transformational therapies that make a real difference to patients with serious and rare diseases.
Who is eligible to participate?
To be considered for inclusion in the CONVERT study, you must:
- Be 18 years of age or older
- Have an active lung infection caused by Mycobacterium avium Complex (MAC) and have not improved on previous treatments
- Not be pregnant, trying to become pregnant, or nursing a baby
- Not have cystic fibrosis, active tuberculosis, or a history of lung transplant
- Have not tested positive for HIV
- Be willing to use specific medicine for the duration of the study
- Meet all the requirements needed for participation in the study
Other study requirements will be reviewed in detail by site study staff. Eligible participants will have a 2-in-3 (66%) chance of being assigned to the investigational antibiotic treatment group (LAI).
What is the time commitment involved?
The CONVERT study consists of 3 phases: Screening, treatment, and follow-up. The total time
commitment is up to 31 months.
Is there any cost to participate in the study?
You do not have to pay for study visits, LAI, the eFlow® nebulizer, cleaning equipment, or any tests that are part of the study. All vials of used or unused LAI and the nebulizer must be returned at the end of your participation in the study.
You (and/or your health insurance company) will be expected to pay for procedures or tests that are considered standard of care for your condition as these would have been recommended or performed initially regardless of your participation in the CONVERT study.
Why should I consider participating?
By participating in the CONVERT study, you contribute to the understanding of lung infections due to MAC, how the body processes LAI, and whether successful treatment with LAI can help improve physical function and quality of life.