What are the inclusion criteria for Ensifentrine (PDE3/4 inhibitor) treatment in patients with chronic obstructive pulmonary disease (COPD)?

Inclusion Criteria for Ensifentrine Treatment in COPD

Ensifentrine is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients who remain symptomatic despite current therapy, particularly those with a history of exacerbations. 1

Patient Selection Criteria

Primary Inclusion Criteria

• Adult patients with confirmed COPD diagnosis 1
• Moderate to severe COPD (post-bronchodilator FEV1 40-80% predicted) 2, 3
• Symptomatic despite current maintenance therapy 4
• Ages 40-80 years 3

Clinical Scenarios for Ensifentrine Use

1. Patients on LAMA therapy with persistent symptoms

   • Ensifentrine showed significant lung function improvement (placebo-corrected FEV1 increase of 92 mL) 4
   • 48% reduction in exacerbation rate when added to LAMA therapy 4

2. Patients on LABA+ICS therapy with persistent symptoms

   • Ensifentrine provided additional lung function improvement (placebo-corrected FEV1 increase of 74 mL) 4
   • 51% reduction in exacerbation rate when added to LABA+ICS therapy 4

3. Patients with history of exacerbations

   • Ensifentrine reduced moderate to severe exacerbation rate by 41% (rate ratio 0.59) 5
   • Increased time to first exacerbation (hazard ratio 0.59) 5
   • May delay transition from infrequent to frequent exacerbator phenotype 5

Administration Considerations

• Administered as 3 mg (one ampule) twice daily via standard jet nebulizer with mouthpiece 1
• Nebulization time is approximately 7 minutes 1
• Ampule should be shaken vigorously before administration 1

Contraindications and Cautions

• Contraindicated in patients with hypersensitivity to ensifentrine or any component of the product 1
• Use with caution in patients with:
  • Moderate hepatic impairment (increased drug exposure) 1
  • History of depression or suicidal thoughts (increased risk of psychiatric adverse reactions) 1
  • Moderate renal impairment (25% reduction in clearance) 1

Monitoring and Follow-up

• Regular assessment of:
  • Symptoms and exacerbation frequency
  • Lung function
  • Adverse events (most common: back pain, hypertension, urinary tract infection, and diarrhea) 1
  • Signs of psychiatric adverse reactions including suicidality 1

Important Clinical Considerations

• Ensifentrine should not be used to treat acute symptoms of bronchospasm 1
• If paradoxical bronchospasm occurs, discontinue ensifentrine and institute alternative therapy 1
• Ensifentrine offers a novel mechanism as a dual PDE3/4 inhibitor with both bronchodilator and anti-inflammatory effects 3
• Consider ensifentrine as an add-on therapy for patients still experiencing symptoms despite treatment with currently recommended therapies 6

Ensifentrine represents a new therapeutic option for COPD patients who remain symptomatic despite standard therapies, with demonstrated benefits in lung function, symptom improvement, and exacerbation reduction across various patient subgroups.