A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
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|ClinicalTrials.gov Identifier: NCT04685720|
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : December 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Tuberculous Mycobacterial Pneumonia Cystic Fibrosis Mycobacterial Pneumonia Mycobacterium Abscessus Infection Mycobacterium Avium Complex||Device: LungFit||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess the Effect of Intermittent Inhaled Nitric Oxide on the Treatment of Nontuberculous Mycobacteria (NTM) Lung Infection in Cystic Fibrosis and Non-Cystic Fibrosis Patients|
|Actual Study Start Date :||December 7, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Inhaled NO delivered using LungFit
Inhaled Nitric Oxide in doses up to 250 ppm
LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.
- Treatment-Emergent SAEs [ Time Frame: Day 1 to Day 84 ]The primary endpoint of the study is the number of patients with treatment-emergent SAEs
- Changes in NTM bacterial load from baseline to Day 174 [ Time Frame: Day 1 to Day 174 ]Changes in NTM bacterial load will be assessed by sputum culture in liquid and solid media.
- Number of patients with culture conversion at Day 174 [ Time Frame: Day 1 to Day 174 ]NTM culture conversion will be defined as having at least three consecutive negative NTM cultures
- Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module [ Time Frame: Day 1 to Day 174 ]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.
- Changes in FEV1 from baseline to Day 174 [ Time Frame: Day 1 to Day 174 ]Respiratory function will be assessed by spirometry including FEV1.
- Changes in activity tracker data as assessed by changes in distance from baseline to Day 174. [ Time Frame: Day 1 to Day 174 ]Patients will collect activity tracker data from 2 weeks before treatment and from Day 1 to Day 174.
- Change in 6 Minute Walking Test [ Time Frame: Day 1 to Day 84 ]Change in 6 Minute Walking Test will be assessed by changes in distance between baseline and Day 84
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685720
|Contact: Vladislava Zamfirovafirstname.lastname@example.org|
|Contact: Enoch Borteyemail@example.com|
|Gallipoli Medical Research Foundation||Recruiting|
|Greenslopes, Queensland, Australia, 4120|
|Contact: Rachel Thomson, MD firstname.lastname@example.org|
|Principal Investigator: Rachel Thomson, MD|