A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients

NCT04685720 | Completed DMC

• 1 other identifier: BA_NTM_AU_01.01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Tuberculous Mycobacterial Pneumonia; Cystic Fibrosis; Mycobacterial Pneumonia; Mycobacterium Abscessus Infection; Mycobacterium Avium Complex

Outcome Measures

Primary Outcomes (1)

• Treatment-Emergent SAEs

  The primary endpoint of the study is the number of patients with treatment-emergent SAEs

  Day 1 to Day 84

Secondary Outcomes (6)

• Changes in NTM bacterial load from baseline to Day 174

  Day 1 to Day 174

• Number of patients with culture conversion at Day 174

  Day 1 to Day 174

• Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module

  Day 1 to Day 174

• Changes in FEV1 from baseline to Day 174

  Day 1 to Day 174

• Changes in activity tracker data as assessed by changes in distance from baseline to Day 174.

  Day 1 to Day 174

Study Arms (1)

Inhaled NO delivered using LungFit

EXPERIMENTAL

Inhaled Nitric Oxide in doses up to 250 ppm

Device: LungFit

Interventions

LungFit DEVICE

LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.

Inhaled NO delivered using LungFit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection
• CF and Non-CF patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Beyond Air Inc.: lead

Study Sites (1)

Gallipoli Medical Research Foundation

Greenslopes, Queensland, 4120, Australia

Location

MeSH Terms

Conditions

Cystic Fibrosis; Mycobacterium Infections, Nontuberculous; Mycobacterium avium-intracellulare Infection

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 28, 2020
• Study Start: December 7, 2020
• Primary Completion: July 28, 2022
• Study Completion: October 10, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)