Inhaled Nitric Oxide for Patients With MABSC

Inclusion criteria

• Subjects (Male or female) between 6 to 65 years old
• Diagnosis of pulmonary non-tuberculosis mycobacterial lung disease in accordance with the 2007 ATS/IDSA criteria with evidence of nodular bronchiectasis and/or cavitary disease by chest computed tomography (CT) and by culture.
• History of at least 6 months chronic infection with Mycobacterium abscessus.
• Mycobacterium abscessus positive sputum sample at screening or prior to screening.
• Receiving ATS/IDSA guidelines-based treatment regimen defined as: adherent to a multi-drug regimen for at least 6 months prior to screening with persistently positive mycobacterial abscessus cultures.
• FEV1 ≥ 30% at screening as well as baseline.
• Ability to produce sputum or be willing to undergo an induction of sputum for clinical evaluation.
• Life expectancy ≥1 year
• Ability to perform 6MWT, but not to exceed a distance of 700 meters during screening.
• Ability to understand and comply with study requirements.
• Approved and signed informed consent by subject and/or by parent/legal guardian (depending on subject's age).

Exclusion criteria

• Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
• Subjects diagnosed with methemoglobinemia, immunodeficiency, heart disease, pulmonary hypertension and/or high blood pressure.
• Use of an investigational drug during the last 30 days prior enrollment and/or the subject is expected to participate in a new study within five months from enrollment to this study.
• History of frequent epistaxis (>1 episode/month).
• Significant hemoptysis during the last 30 days prior to enrolment (>30 Ml of blood in a 24-hour period).
• Methemoglobin level >2% at screening.
• Patients on inconsistant dosage of systemic steroids (any formulation) 30 days prior to enrolment.
• History of illicit drug or medication abuse within 1 year of screening.
• History of lung transplantation.
• History of daily, continuous oxygen supplementation.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
• Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
• Any change in chronic NTM multi-drug regimen within 28 days prior to study day 1.