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Last reviewed: 10 Nov 2024
Last updated: 26 Jul 2024
26 Jul 2024

US FDA approves ensifentrine for maintenance treatment

The US Food and Drug Administration (FDA) has approved ensifentrine ​for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.

Ensifentrine, a first-in-class dual selective phosphodiesterase (PDE)-3 and PDE-4 inhibitor, combines both bronchodilator and nonsteroidal anti-inflammatory effects within a single molecule delivered via a standard jet nebulizer.

In phase 3 randomized placebo-controlled trials of patients with symptomatic moderate to severe COPD, ensifentrine:​[229]

  • improved lung function at 12 weeks

  • reduced moderate or severe exacerbation rate over 24 weeks

  • appeared to be well-tolerated; a similar proportion of patients reported adverse events in treatment and placebo groups.

Ensifentrine is expected to become commercially available in the US later in 2024, and is not approved in Europe as yet.

See Management: emerging

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • cough
  • shortness of breath
  • sputum production
  • exposure to risk factors

Other diagnostic factors

  • barrel chest
  • hyperresonance on percussion
  • distant breath sounds on auscultation
  • poor air movement on auscultation
  • wheezing on auscultation
  • coarse crackles
  • tachypnea
  • asterixis
  • distended neck veins
  • lower-extremity swelling
  • fatigue
  • weight loss
  • muscle loss
  • headache
  • pursed lip breathing
  • cyanosis
  • loud P2
  • hepatojugular reflux
  • hepatosplenomegaly
  • clubbing

Risk factors

  • cigarette smoking
  • advanced age
  • genetic factors
  • lung growth and development
  • white ancestry
  • exposure to air pollution
  • exposure to burning solid or biomass fuel
  • occupational exposure to dusts, chemicals, pesticides, vapors, fumes, or gases
  • male sex
  • low socioeconomic status
  • rheumatoid arthritis

Diagnostic tests

1st tests to order

  • spirometry
  • standardized symptoms score
  • pulse oximetry
  • ABG
  • CXR
  • CBC

Tests to consider

  • pulmonary function tests
  • chest CT scan
  • serial peak flow measurement
  • sputum culture
  • alpha-1 antitrypsin level
  • exercise testing
  • sleep study
  • respiratory muscle function
  • ECG
  • echocardiogram
  • blood eosinophil count

Treatment algorithm

Contributors

Authors

Manoochehr Abadian Sharifabad, MD
Manoochehr Abadian Sharifabad

Fountain Valley Regional Medical Center

Fountain Valley

CA

Disclosures

MAS declares that he has no competing interests.

Acknowledgements

Dr Manoochehr Abadian Sharifabad would like to gratefully acknowledge Dr Jonathan P. Parsons and Dr Michael Ezzie, the previous contributors to this topic.

Disclosures

JPP has contributed at speakers' bureaus for GlaxoSmithKline, Inc., Schering-Plough, Inc., and AstraZeneca, Inc. ME declares that he has no competing interests.

Peer reviewers

Hormoz Ashtyani, MD, FCCP

Hackensack University Medical Center

Hackensack

NJ

Disclosures

HA declares that he has no competing interests.

Alejandro Comellas, MD

Clinical Professor of Internal Medicine-Pulmonary, Critical Care and Occupational Medicine

University of Iowa

Iowa City

IA

Disclosures

AC has received payments as a consultant for GSK and AstraZeneca. He also serves as a nonpaid consultant for VIDA.

William Janssen, MD

Assistant Professor of Medicine

National Jewish Medical and Research Center

University of Colorado Health Sciences Center

Denver

CO

Disclosures

WJ declares that he has no competing interests.

Francis Thien, MD, FRACP, FCCP

Associate Professor

Director of Respiratory Medicine

Eastern Health & Monash University

Victoria

Australia

Disclosures

FT declares that he has no competing interests.

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