Clinical Trials

This is a frontline clinical trial program of ARIKAYCE^® (amikacin liposome inhalation suspension) in patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC), consisting of ARISE, an interventional study designed to validate cross-sectional and longitudinal characteristics of patient-reported outcome (PRO) tools in MAC lung disease, and ENCORE, a pivotal trial designed to establish, using the PRO tools validated in the ARISE trial, the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed MAC lung disease. For more information, click here to visit the ARISE/ENCORE study page.

The IMPALA-2 clinical trial is investigating molgramostim nebulizer solution (molgramostim) for the potential treatment of aPAP.

Read more about the clinical trial and aPAP here.

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 MAC2v3@ohsu.edu if you are interested in participating and providing this opportunity to your patients.

Learn More Here

I am very pleased to announce the launch of our new pilot program, aimed at bringing better care to patients with NTM lung disease.

The COPD Foundation and NTM Info & Research, in partnership with a team of experts at National Jewish Health has designed a pilot program aimed at improving the current process for sputum testing. There will be no cost to the patient or physician as part of this pilot program.

Now more than ever, the need for accurate home testing is essential, particularly for medically vulnerable patient populations. We hope this pilot program will demonstrate that:

• Patients are able to provide sputum samples in the home setting

• We can improve timelines of results and provide access to increased species identification and drug susceptibility testing

• Home sputum collection provides a safe and accessible alternative to producing sputum in the laboratory setting

To learn more about the Home Sputum Collection Project and eligibility criteria, visit www.homesputum.org. Physicians interested in participating must complete an initial screening survey here.

Now recruiting participants for an interview and questionnaire-only research study of
NTM MAC lung disease
We are currently recruiting patients with NTM MAC lung disease to participate in a research
study being conducted by Evidera, a research organization, with funding from AN2
Therapeutics, a biopharmaceutical company.

Study Goals: The goal of this interview study is to better understand the symptoms and
impacts of MAC lung disease to help Evidera pick or create questionnaires to be used in
treatment studies of this disease.

• Study Activities: If you qualify and choose to participate, you will be asked to do the following:
  Have your medical team complete a brief form that confirms you meet study
  requirements
• Sign an electronic consent form and complete a few questionnaires about your health
  and your demographics (age, sex, race, etc.)
• Participate in a telephone interview lasting about 60 minutes with a researcher from
  Evidera. During the interview, you will be asked to describe the symptoms and impacts
  you experience as a result of MAC lung disease.
  You will not receive any treatment as part as this study. You will receive $200 if you complete
  all of the above activities.

To Learn More: If you are interested in learning more, please contact Evidera at
NTMlungstudy@ppd.com or toll-free at 877-888-3232.

Search for pending or recruiting clinical trials on clinicaltrials.gov

A 2-part multi-center, Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of RHB-204 in adult subjects with underlying nodular bronchiectasis and documented MAC lung infection. Learn More.

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.

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.

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.

The PREDICT study will help standardize the diagnosis and collect relevant data associated with the diagnosis of NTM disease in CF patients to build a framework for future therapeutic trials. Learn more.

The PATIENCE study will help standardize the diagnosis and collect relevant data associated with the treatment of NTM disease in CF patients to build a framework for future therapeutic trials. Learn more.