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.
Summary
Definition
History and exam
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
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
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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