Exhaled nitric oxide

Tezepelumab Regulatory Submission Accepted and Granted FDA Priority Review in the US for the Treatment of Patients with Asthma

Retrieved on: 
Thursday, July 8, 2021

These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patients blood (eosinophils/IgE) and exhaled air (FeNO).

Key Points: 
  • These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patients blood (eosinophils/IgE) and exhaled air (FeNO).
  • There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.
  • NAVIGATOR is the first Phase III trial to show benefit in severe asthma irrespective of eosinophils by targeting thymic stromal lymphopoietin (TSLP).
  • These results support the US Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.

Pivotal data at ATS 2021 show Dupixent® (dupilumab) significantly reduced asthma attacks and improved lung function in children

Retrieved on: 
Monday, May 17, 2021

Dupixent also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma, called fractional exhaled nitric oxide (FeNO).

Key Points: 
  • Dupixent also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma, called fractional exhaled nitric oxide (FeNO).
  • Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing.
  • They also may require the use of multiple courses of systemic corticosteroids that carry significant risks.
  • Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP.

Steps to Avoid Illness from Infectious Diseases by Dr. Nathan S. Bryan: Nitric Oxide May Be the Key

Retrieved on: 
Tuesday, April 28, 2020

Together, the data revealed that decreased nitric oxide production explains these findings.

Key Points: 
  • Together, the data revealed that decreased nitric oxide production explains these findings.
  • In fact, there are a number of clinical studies using inhaled nitric oxide in critically ill patients.However, we need nitric oxide prior to escalation of respiratory distress and need nitric oxide prior to hospitalization.
  • Furthermore, we need systemic increases in nitric oxide, not just in the airways and pulmonary circulation.
  • Steps to avoid illness from infectious disease:
    Increase your nitric oxide levels.

Dupixent® (dupilumab) Approved for Severe Asthma by European Commission

Retrieved on: 
Tuesday, May 7, 2019

Only biologic approved in the EU for severe asthma with type 2 inflammation, as characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO)

Key Points: 
  • Only biologic approved in the EU for severe asthma with type 2 inflammation, as characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO)
    In clinical trials, Dupixent improved lung function and quality of life, and reduced severe exacerbations and oral corticosteroid use
    Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) approved a new indication for Dupixent (dupilumab) in asthma.
  • QUEST enrolled 1,902 patients with persistent asthma and evaluated whether adding Dupixent to standard-of-care therapy could reduce severe exacerbations and improve lung function (measured by FEV1).
  • VENTURE enrolled 210 patients with severe oral corticosteroid-dependent asthma and evaluated whether adding Dupixent to standard-of-care therapy could reduce the use of maintenance oral corticosteroids.
  • DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing.

Spirosure Receives FDA Clearance to Sell Its Point-of-Care Asthma Monitor, Fenom Pro™

Retrieved on: 
Monday, February 25, 2019

Spirosure Inc. announced today that it has received FDA clearance of its patent-protected Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma by measuring the fraction of exhaled nitric oxide (FeNO) in their patients breath.

Key Points: 
  • Spirosure Inc. announced today that it has received FDA clearance of its patent-protected Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma by measuring the fraction of exhaled nitric oxide (FeNO) in their patients breath.
  • Spirosure's Fractional exhaled Nitric Oxide (FeNO)-based Fenom Pro Asthma Monitor uses state-of-the-art technology with proprietary algorithms to detect exhaled nitric oxide (NO) molecules in concentrations of parts per billion (or ppb) in human breath.
  • FeNO measurement with Fenom Pro is designed to be used as part of regular assessment of patients by healthcare professionals and for monitoring of patients with asthma.
  • Fenom Pro is a game-changing device for asthma management, said Dr. Solomon Ssenyange, Chairman and CEO of Spirosure.