Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Not applicable
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/study/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04685720