The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.
The study will include 20 patients from up to four clinical sites in Australia. The overall treatment plan includes 2 weeks of inhalation treatments (intensive phase) of iNO four times per day at 4.5-hour intervals followed by 10 weeks of inhalation treatments (maintenance phase) at the maximum tolerated dose (a maximum of 250 ppm NO) inhaled twice daily.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Treatment-Emergent SAEs
The primary endpoint of the study is the number of patients with treatment-emergent SAEs
Time frame: Day 1 to Day 84
Changes in NTM bacterial load from baseline to Day 174
Changes in NTM bacterial load will be assessed by sputum culture in liquid and solid media.
Time frame: Day 1 to Day 174
Number of patients with culture conversion at Day 174
NTM culture conversion will be defined as having at least three consecutive negative NTM cultures
Time frame: Day 1 to Day 174
Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module
Changes in quality of life assessed by Cystic Fibrosis Questionnaire Revised \[CFQ R\] for CF patients or Quality of Life Questionnaire-Bronchiectasis \[QOL-B\] with NTM module for non-CF patients.
Time frame: Day 1 to Day 174
Changes in FEV1 from baseline to Day 174
Respiratory function will be assessed by spirometry including FEV1.
Time frame: Day 1 to Day 174
Changes in activity tracker data as assessed by changes in distance from baseline to Day 174.
Patients will collect activity tracker data from 2 weeks before treatment and from Day 1 to Day 174.
Time frame: Day 1 to Day 174
Change in 6 Minute Walking Test
Change in 6 Minute Walking Test will be assessed by changes in distance between baseline and Day 84
Time frame: Day 1 to Day 84
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.