Inhaled Nitric Oxide for Patients With MABSC (NCT03208764) | Clinical Trial Compass
CompletedPhase 2
Inhaled Nitric Oxide for Patients With MABSC
Israel9 participantsStarted 2017-07-24
Plain-language summary
A Prospective, Open labeled, multi-Center, Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently via Inhalation to Subjects with NTM (specifically MABSC)
Nitric Oxide (NO) has been shown to play a critical role in various biological functions. In the airways, NO is considered to play a key role in the innate immune system in which the first-line of host defense against microbes is built.
In vitro studies suggested that NO, in part per million (ppm) concentrations, possesses anti-microbial activity against a wide variety of phyla including fungi, and antibiotic-resistance bacteria.
In this study the investigators wish to evaluate the efficacy, safety and tolerability of 160 ppm Nitric Oxide intermittently delivered via inhalation to subjects infected with Non-tuberculosis mycobacteria (NTM), specifically with MABSC.
Who can participate
Age range6 Years
SexALL
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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
Exclusion criteria
✕
What they're measuring
1
Safety measured by NO-related Serious Adverse Events
. 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.