CLINICAL TRIALS
Do you have Nontuberculous
Mycobacterial (NTM) Pulmonary Disease?
You can search for pending or recruiting clinical trials through the National Library of Medicine’s clinical trials website, clinicaltrials.gov.
This site also maintains a list of recruiting studies. If you are a principal investigator or study site and wish to add an IRB-approved trial to our listings, or if you wish to have your study information amended or removed from ntminfo.org, please email
nt*****@nt*****.org
.
ARISE/ENCORE CLINICAL TRIAL PROGRAM FOR MAC LUNG DISEASE
Insmed is conducting a clinical study for MAC lung disease patients. The results of this study will help researchers gain a better understanding of a study treatment being evaluating for potential treatment of MAC lung infections and for improved symptoms including decreased respiratory discomfort and fatigue. You may receive study-related treatment at no cost and reimbursements for your site visits. If you qualify to enroll and decide to participate, you will be assigned to one of two studies for individuals with MAC lung disease. Please visit ntmlungstudy.com to learn more about the study and to see if you may qualify.
Further Details and Next Steps:
• First, see if you may qualify using the website linked above. A patient outreach representative will call you and help guide you through the process.
• Then, a research site will assess if you meet the criteria to participate in the study. If you qualify you will be assigned to one of two studies.
• Throughout the study, you will take daily study drugs and have visits with your clinical team.
CLOFAZIMINE IN THE TREATMENT OF PULMONARY NONTUBERCULOUS MYCOBACTERIUM AVIUM COMPLEX (MAC)
Investigators have developed a randomized, placebo-controlled clinical trial to assess the clinical efficacy and safety of clofazimine when used to treat MAC lung disease. Learn more.
ICoN-1 STUDY OF INHALED CLOFAZIMINE FOR ADULTS WITH NTM CAUSED BY MAC
Randomized, double-blind, placebo-controlled study (Part A) designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT). The primary objective of this study will be to compare the efficacy of Clofazimine Inhalation Suspension versus placebo as assessed by the co-primary endpoints, sputum culture conversion and change in Quality of Life-Bronchiectasis Respiratory Symptoms Score (QoL-B RSS). An open label extension study (Part B) will be offered to qualified participants for treatment with Clofazimine Inhalation Suspension. Learn more.
EVALUATION OF THE LUNG MICROBIOME IN NTM BRONCHIECTASIS
A biomarker cohort study design is proposed to study whether specific airway microbiota alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. Learn more.
FINDING THE OPTIMAL REGIMEN FOR MYCOBACTERIUM ABSCESSUS TREATMENT
We are looking for people to be part of our Consumer Advisory Group to provide their say on how treatments for a rare lung condition are being tested. Please contact us at
fo*********@he****.au
for further information and to apply! Learn more.
TRIKAFTA FOR PATIENTS WITH NON-CYSTIC FIBROSIS BRONCHIECTASIS
Study participants with non-cystic fibrosis bronchiectasis will be given Trikafta for four weeks. The researchers will monitor clinical endpoints, quality of life, and weight. Additionally, cutaneous punch biopsy material will be collected from each participant to test cellular response to Trikafta. Learn more.
MAC INFECTION AND ENVIRONMENTAL TESTING
MAC infection and environmental testing: A sequencing study that will assess whether the MAC from lung disease patients matches the MAC cultured from the home environment. Learn more
MAC2V3 PRAGMATIC CLINICAL TRIAL
We are a team of researchers at Oregon Health and Science University and 20+ partner sites across the United States and Canada conducting a Patient-Centered Research Outcomes Institute (PCORI)-funded pragmatic trial to determine whether 2-drug therapy is as effective as and more tolerable than 3-drug therapy for pulmonary MAC disease, or “MAC2v3”.
Clinicaltrials.gov Information Page with eligibility criteria: https://clinicaltrials.gov/ct2/show/NCT03672630
Let us support you with guidance from NTM experts as your uncomplicated pulmonary MAC patients begin treatment! MAC2v3 study participation has been expanded to include virtual enrollment and telehealth visits. The study team is now able to enroll patients from any health care provider nationwide. However, we need to enroll them prior to starting treatment. Once randomized, patients are monitored per usual care in collaboration with your clinic. Data collection is managed by the enrolling site. Please contact
MA****@oh**.edu
if you are interested in participating and providing this opportunity to your patients.
NATIONAL LIBRARY OF MEDICINE CLINICAL TRIALS LISTINGS
Search for pending or recruiting clinical trials on clinicaltrials.gov
PROSPECTIVE ALGORITHM FOR TREATMENT OF NTM IN CYSTIC FIBROSIS (PATIENCE)
STUDY OF MYCOBACTERIAL INFECTIONS
This study will examine the symptoms, course of disease and treatment of non-tuberculous mycobacterial (NTM) infections, as well as the genetics involved in these infections. Learn more.
VOLUNTEERS NEEDED FOR RESEARCH STUDY IN AUSTRALIAN PATIENTS WITH NTM LUNG INFECTION
220,000
ESTIMATED CASES
OF NTM IN THE US
IN 2020
8.2 %
THE RISE IN THE
NUMBER OF NTM CASES
EACH YEAR
2.8m
ANTIBIOTIC-
RESISTANT INFECTIONS
IN THE US EACH YEAR
