Trials / Completed
CompletedNCT04685720
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Beyond Air Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Non-Tuberculous Mycobacterial Pneumonia
- Cystic Fibrosis
- Mycobacterial Pneumonia
- Mycobacterium Abscessus Infection
- Mycobacterium Avium Complex
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LungFit | LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air. |
Timeline
- Start date
- 2020-12-07
- Primary completion
- 2022-07-28
- Completion
- 2022-10-10
- First posted
- 2020-12-28
- Last updated
- 2022-12-16
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04685720. Inclusion in this directory is not an endorsement.