ENHANCE-1
Trial question
What is the role of ensifentrine in patients with COPD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 760
760 patients (319 female, 441 male).
Inclusion criteria: adult patients aged 40-80 years with moderate-to-severe symptomatic COPD.
Key exclusion criteria: asthma; chronic uncontrolled disease; malignancy of any organ system; history of life-threatening COPD; COPD exacerbation requiring corticosteroids in the past 3 months; previous lung resection or lung reduction surgery in the past year.
Interventions
N=477 ensifentrine (at a dose of 3 mg BID).
N=283 placebo (matching placebo BID).
Primary outcome
Mean improvement in forced expiratory volume in 1 second area under curve at 0-12 hours
61 mL
-26 mL
61.0 mL
45.8 mL
30.5 mL
15.3 mL
0.0 mL
-15.3 mL
-30.5 mL
Ensifentrine
Placebo
Significant
increase ▲
Significantly greater improvement in mean FEV1 AUC at 0-12 hours (61 mL vs. -26 mL; MD 87, 95% CI 55 to 119).
Secondary outcomes
Significantly greater improvement in mean peak FEV1 at week 12 (204 mL vs. 57 mL; MD 147, 95% CI 111 to 183).
Significantly greater improvement in mean morning trough FEV1 at week 12 (8 mL vs. -27 mL; MD 35, 95% CI 1 to 68).
Significantly greater reduction in mean Evaluating Respiratory Symptoms total score at week 24 (2.2 points vs. 1.3 points; MD 1, 95% CI 0.2 to 1.7).
Safety outcomes
No significant difference in any treatment-emergent adverse events.
Conclusion
In adult patients aged 40-80 years with moderate-to-severe symptomatic COPD, ensifentrine was superior to placebo with respect to mean improvement in FEV1 AUC at 0-12 hours.
Reference
Antonio Anzueto, Igor Z Barjaktarevic, Thomas M Siler et al. Ensifentrine, a Novel Phosphodiesterase 3 and 4 Inhibitor for the Treatment of Chronic Obstructive Pulmonary Disease: Randomized, Double-Blind, Placebo-controlled, Multicenter Phase III Trials (the ENHANCE Trials). Am J Respir Crit Care Med. 2023 Aug 15;208(4):406-416.
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