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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04685720




Registration number
NCT04685720
Ethics application status
Date submitted
7/12/2020
Date registered
28/12/2020
Date last updated
16/12/2022

Titles & IDs
Public title
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
Scientific 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
Secondary ID [1] 0 0
BA_NTM_AU_01.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Tuberculous Mycobacterial Pneumonia 0 0
Cystic Fibrosis 0 0
Mycobacterial Pneumonia 0 0
Mycobacterium Abscessus Infection 0 0
Mycobacterium Avium Complex 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - LungFit

Experimental: Inhaled NO delivered using LungFit - Inhaled Nitric Oxide in doses up to 250 ppm


Treatment: Devices: LungFit
LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-Emergent SAEs
Timepoint [1] 0 0
Day 1 to Day 84
Secondary outcome [1] 0 0
Changes in NTM bacterial load from baseline to Day 174
Timepoint [1] 0 0
Day 1 to Day 174
Secondary outcome [2] 0 0
Number of patients with culture conversion at Day 174
Timepoint [2] 0 0
Day 1 to Day 174
Secondary outcome [3] 0 0
Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module
Timepoint [3] 0 0
Day 1 to Day 174
Secondary outcome [4] 0 0
Changes in FEV1 from baseline to Day 174
Timepoint [4] 0 0
Day 1 to Day 174
Secondary outcome [5] 0 0
Changes in activity tracker data as assessed by changes in distance from baseline to Day 174.
Timepoint [5] 0 0
Day 1 to Day 174
Secondary outcome [6] 0 0
Change in 6 Minute Walking Test
Timepoint [6] 0 0
Day 1 to Day 84

Eligibility
Key inclusion criteria
- Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection

- CF and Non-CF patients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of methemoglobinemia or MetHb =2% at screening; treatment with any drug
known to increase MetHb; known or suspected hemoglobinopathy.

- History of or current myeloproliferative disease, leukemia or other hematological
malignancy; known or suspected immunodeficiency disease.

- Subjects with advanced cardiovascular disease or CHF

- Use of an investigational drug during the 30 days prior to enrollment.

- History of frequent epistaxis (>1 episode/month); significant hemoptysis (during the
30 days prior to enrollment.

- Subject on non-constant dose of systemic steroids within 30 days prior to enrollment;
subjects on constant systemic steroids if the daily dose is higher than 10 mg/d
prednisolone or equivalent.

- Active pulmonary malignancy (primary or metastatic) or any malignancy; history of lung
transplantation.

- Pulmonary tuberculosis requiring treatment or treated within 2 years prior to
screening.

- Uncontrolled hypertension within 3 months prior to or at screening

- Diagnosis of significant pulmonary hypertension indicated on echocardiogram at
screening

- Clinically significant renal or liver laboratory abnormalities

- History of daily, continuous oxygen supplementation.

- Women of childbearing potential - pregnant or breastfeeding, or not on medically
acceptable double methods of contraception from enrollment until Day 84.

- Smoking tobacco or any substance within 6 months prior to screening or anticipated
inability to refrain from smoking throughout the study.

- Patient receiving drugs that have a contraindication with NO

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/10/2022
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gallipoli Medical Research Foundation - Greenslopes
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Beyond Air Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04685720
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries