Lungfit BRO (nitric oxide) / Beyond Air - LARVOL DELTA

A Pilot Study to Assess the Effect of Intermittent Inhaled Nitric Oxide as Treatment of Nontuberculous Mycobacteria Lung Infection. (PubMed, Ann Am Thorac Soc) - No abstract available

Journal • Infectious Disease • Nontuberculous Mycobacterial Disease • Respiratory Diseases

Evaluation of Inhaled Nitric Oxide Generation Systems at Altitude. (PubMed, Mil Med) - "Both devices delivered a reliable INO dose at ground level. Altitude significantly affected INO delivery accuracy at 14,000 ft (4,267 meter) (P  0.05) although there were large variations with selected ventilator settings. With careful monitoring, devices creating INO from room air without cylinders could be used during aeromedical transport without the need for pressurized cylinders."

Journal • Cardiovascular • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A safety evaluation of intermittent high-dose inhaled nitric oxide in viral pneumonia due to COVID-19: a randomised clinical study. (PubMed, Sci Rep) - "Among the Treatment-Group, oxygen support duration was reduced by 2.7 days (Hazard Ratio = 2.8; p = 0.0339), a greater number of subjects reached oxygen saturation ≥ 93% within hospitalisation period (Hazard Ratio = 5.4; p = 0.049), and a trend for earlier discharge was demonstrated. Intermittent 150-ppm iNO-treatment is well-tolerated, safe, and beneficial compared to usual care for spontaneously breathing hospitalised adults diagnosed with COVID-19 viral pneumonia."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients (clinicaltrials.gov) - P=N/A | N=15 | Completed | Sponsor: Beyond Air Inc. | Recruiting ➔ Completed | Trial completion date: May 2022 ➔ Oct 2022 | Trial primary completion date: Dec 2021 ➔ Jul 2022

Nontuberculous mycobacteria • Trial completion • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Nontuberculous Mycobacterial Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Inhaled NO for the Treatment of Viral Pneumonia in Adults (clinicaltrials.gov) - P=N/A | N=40 | Completed | Sponsor: Beyond Air Inc. | Recruiting ➔ Completed | N=90 ➔ 40

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

HOME-BASED TREATMENT OF NONTUBERCULOUS MYCOBACTERIA PULMONARY DISEASE VIA A NOVEL NITRIC OXIDE GENERATOR AND DELIVERY SYSTEM (CHEST 2022) - "Overall, the intermittent high dose NO treatment regimen has been well-tolerated in both the hospital and home settings. Using the easy-to-operate and compact novel NO generator, all patients demonstrated ability to be trained to self-administer therapies at home. CLINICAL IMPLICATIONS: Beneficial outcomes of NO in NTM disease are anticipated due to its antimicrobial effects, and further clinical studies are required to establish the benefit of the treatment."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

Inhaled Nitric Oxide for the Treatment of Acute Bronchiolitis: A Multicenter Randomized Controlled Trial to Evaluate Dose Response. (PubMed, Ann Am Thorac Soc) - "Treatment with high dose intermittent iNO at 150 ppm showed reduced time to clinical improvement when compared to 85 ppm or control treatment of hospitalized infants with acute bronchiolitis. The 150 ppm iNO dose is well-tolerated, with significant benefit compared to both standard therapy and 85 ppm iNO, improving respiratory outcome and reducing length of stay."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Characterization of Inhaled Nitric Oxide (iNO) for the treatment of Viral Community Acquired Pneumonia (CAP) (IDWeek 2022) - No abstract available

Infectious Disease

Home-Based Intermittent Inhaled High-Dose Nitric Oxide in Nontuberculous Mycobacterial Pulmonary Disease Using a Novel Nitric Oxide Generator and Delivery System Is Safe and Well Tolerated (ATS 2022) - "Overall, the intermittent high-dose NO treatment regimen has been well-tolerated in the hospital and home settings, with patients demonstrating the ability to be trained to self-administer treatments using this novel NO generation and delivery device and early improvements in QOL-B (NTM). Given the antimicrobial, anti-inflammatory, and direct pulmonary vasodilation effects of NO, beneficial effects of NO treatment on NTM lung infections are anticipated."

Bronchiectasis • Cardiovascular • Non‐Cystic Fibrosis Bronchiectasis • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

Treatment of COVID-19 with inhaled nitric oxide using a novel nitric oxide generator (ECCMID 2022) - No abstract available

Infectious Disease • Novel Coronavirus Disease

Inhaled NO for the Treatment of Viral Pneumonia in Adults (clinicaltrials.gov) - P=N/A | N=90 | Recruiting | Sponsor: Beyond Air Inc. | Trial completion date: Sep 2021 ➔ Sep 2022 | Trial primary completion date: Sep 2021 ➔ Sep 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

[VIRTUAL] Efficacy and Safety of Inhaled Nitric Oxide for the Treatment of Acute Bronchiolitis: An Evaluation of Three Trials (ATS 2021) - "Analysis across the three studies demonstrated that a short course of treatments with intermittent high concentration iNO (150 or 160 ppm) was effective in accelerating time to SpO2 of ≥ 92% and shortening hospital LOS. The 85 ppm NO group did not demonstrate efficacy compared to the SST group. The data indicate the efficacy and safety of intermittent administration of 150 or 160 ppm iNO in the treatment of infants with acute bronchiolitis."

Clinical • Infectious Disease • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Inhaled Nitric Oxide for the Treatment of COVID-19 and Other Viral Pneumonias in Adults (ATS 2021) - "Based on current data demonstrating the antiviral and anti-inflammatory effects of NO, in addition to its complex beneficial effect on oxygenation, iNO delivered by the LungFit system has the potential to treat viral pneumonias including COVID-19, thereby providing therapy for this currently unmet medical need."

Clinical • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

Beyond Air Presents Data in Hospitalized Patients with Viral Lung Infections (including COVID-19) from LungFit PRO Programs at ATS 2021 (GlobeNewswire) - P=NA, N=90; NCT04606407; Sponsor:Beyond Air Inc.; "Beyond Air, Inc....announced the presentation of data at the American Thoracic Society (ATS) International Conference 2021...The data from both LungFit® PRO programs, acute viral pneumonia (including COVID-19) and bronchiolitis, show a favorable safety profile and encouraging efficacy trends...150 ppm NO treatment administered via LungFit® PRO was safe and well tolerated....There were no treatment-related, or possibly related, adverse events or severe adverse events....In the ITT population (n=19), 22.2% of subjects in the NO + SST group required oxygen support beyond their hospital stay, compared with 40% of control subjects. Additional detailed study results will be submitted for presentation at an upcoming scientific meeting."

Clinical data • Infectious Disease • Novel Coronavirus Disease

A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients (clinicaltrials.gov) - P=N/A; N=20; Recruiting; Sponsor: Beyond Air Inc.

Clinical • New trial • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Nontuberculous Mycobacterial Disease • Pneumonia • Respiratory Diseases

Inhaled NO for the Treatment of Viral Pneumonia in Adults (clinicaltrials.gov) - P=N/A; N=90; Recruiting; Sponsor: Beyond Air Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Inhaled NO for the Treatment of Viral Pneumonia in Adults (clinicaltrials.gov) - P=N/A; N=90; Not yet recruiting; Sponsor: Beyond Air Inc.

Clinical • New trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial) (clinicaltrials.gov) - P=N/A; N=20; Recruiting; Sponsor: Beyond Air Ltd; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Beyond Air Receives Approval from Health Canada to Study Nitric Oxide Generated and Delivered by the LungFit in COVID-19 Patients (GlobeNewswire, Beyond Air™) - "Beyond Air, Inc....today announced that Health Canada approved the use of the LungFit™ system for a study in hospitalized patients diagnosed with COVID-19 caused by the severe acute respiratory syndrome coronavirus 2....The Canadian COVID-19 study is bifurcated. Part 1 will assess safety at 80 parts per million (ppm) NO, and then, upon the recommendation of a data safety monitoring board (DSMB), Part 2 will begin, which is designed to assess safety and efficacy at 150 ppm NO."

Biomarker • Canadian regulatory • New trial • Infectious Disease • Novel Coronavirus Disease

Beyond Air to present new data in an e-poster presentation at the upcoming AACR Virtual Annual Meeting II on June 22nd to 24th (GlobeNewswire) - "Beyond Air, Inc...announced an e-poster presentation at the upcoming American Association for Cancer Research (AACR) Virtual Annual Meeting II....Title: Gaseous Nitric Oxide at High Concentration is a Powerful Anti-Tumor Agent both in-vitro and in-vivo"

Preclinical • Oncology

Newly added product (GlobeNewswire) - Preclinical, Novel Coronavirus Disease

Pipeline update • Infectious Disease • Novel Coronavirus Disease