Thiolanox (nitric oxide) / Novoteris, Mallinckrodt - LARVOL DELTA

NONTM: Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections (clinicaltrials.gov) - P2; N=13; Terminated; Sponsor: Chris Miller; N=20 ➔ 13; Trial completion date: Mar 2021 ➔ Jun 2021; Recruiting ➔ Terminated; Trial primary completion date: Dec 2020 ➔ Jun 2021; Covid Incidence too low and Funding Completed

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Nontuberculous Mycobacterial Disease • Novel Coronavirus Disease • Respiratory Diseases

Shifting the Treatment Paradigm of Severe Asthma With Novel Biologics - Episode 2: Risk Factors Associated With Asthmatic Episodes (HCPLive) - "Reynold Panettieri, Jr, MD: What are the risk factors? How do you know that an individual sitting next to you is going to have an exacerbation? Geoffrey Chupp, MD: We know that there are some predictors of exacerbations. Eosinophil [leukocyte] counts and exhaled nitric oxide [FeNO] levels have been shown to correlate with a higher risk of an exacerbation....Nicola Hanania, MD, MS: One of the major risk factors is uncontrolled disease, as we will talk about and have already mentioned. Somebody with uncontrolled asthma definitely is at higher risk of exacerbation."

Interview • Video • Asthma

Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients (clinicaltrials.gov) - P2; N=49; Terminated; Sponsor: Novoteris, LLC; Recruiting ➔ Terminated; Terminated for the safety of cystic fibrosis clinical trial subjects due to Covid-19.

Clinical • Trial termination • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases

NONTM: Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Chris Miller; Active, not recruiting ➔ Recruiting

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

Prolonged-Use of Inhaled Gaseous Nitric Oxide (gNO) for Adult With Non-Tuberculous Mycobacteria Infection (clinicaltrials.gov) - P2; N=1; Completed; Sponsor: University of British Columbia; Active, not recruiting ➔ Completed; Trial completion date: Mar 2021 ➔ Jul 2020; Trial primary completion date: Dec 2020 ➔ Jul 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pneumonia • Respiratory Diseases

Mallinckrodt and Novoteris receive clearance from Health Canada to start pilot trial of high-dose inhaled nitric oxide therapy for Covid-19 infection and associated lung complications (Mallinckrodt Press Release) - "Mallinckrodt plc...today announced that the Therapeutic Products Directorate of Health Canada has cleared the companies' joint pilot clinical trial...application to investigate the use of Thiolanox®....The investigative therapy employs Novoteris' Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt's high-concentration, 5000 PPM nitric oxide gas for inhalation canisters....The companies expect to begin recruiting patients in the coming days....Mallinckrodt is currently working with the U.S. Food and Drug Administration on the possibility of making the company's INOmax® (nitric oxide) gas, for inhalation product available to U.S. patients..."

Canadian regulatory • Enrollment open • Regulatory

NONTM: Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections (clinicaltrials.gov) - P2; N=20; Active, not recruiting; Sponsor: University of British Columbia; N=10 ➔ 20; Trial completion date: Dec 2020 ➔ Mar 2021

Clinical • Enrollment change • Trial completion date

Prolonged-Use of Inhaled Gaseous Nitric Oxide (gNO) for Adult With Non-Tuberculous Mycobacteria Infection (clinicaltrials.gov) - P2; N=1; Active, not recruiting; Sponsor: University of British Columbia; Enrolling by invitation ➔ Active, not recruiting; Trial completion date: Mar 2019 ➔ Mar 2021; Trial primary completion date: Dec 2018 ➔ Dec 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Novoteris, LLC; Trial completion date: Dec 2019 ➔ May 2020; Trial primary completion date: Dec 2019 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date

NONTM: Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria Infection (clinicaltrials.gov) - P2; N=10; Active, not recruiting; Sponsor: University of British Columbia; Trial completion date: Dec 2018 ➔ Dec 2020; Trial primary completion date: Dec 2018 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Novoteris, LLC; Trial completion date: May 2019 ➔ Dec 2019; Trial primary completion date: May 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date