ENHANCE-2
Trial question
What is the role of ensifentrine in patients with COPD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 789
789 patients (407 female, 382 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=498 ensifentrine (at a dose of 3 mg BID).
N=291 placebo (matching placebo BID).
Primary outcome
Mean improvement in forced expiratory volume in 1 second area under curve at 0-12 hours
48 mL
-46 mL
48.0 mL
36.0 mL
24.0 mL
12.0 mL
0.0 mL
-12.0 mL
-24.0 mL
-36.0 mL
-48.0 mL
Ensifentrine
Placebo
Significant
increase ▲
Significantly greater improvement in mean FEV1 AUC at 0-12 hours (48 mL vs. -46 mL; MD 94, 95% CI 65 to 124).
Secondary outcomes
Significantly greater improvement in mean peak FEV1 at week 12 (195 mL vs. 48 mL; MD 146, 95% CI 113 to 179).
Significantly greater improvement in mean morning trough FEV1 at week 12 (6 mL vs. -44 mL; MD 49, 95% CI 19 to 80).
No significant difference in mean reduction in Evaluating Respiratory Symptoms total score at week 24 (2.1 points vs. 1.5 points; MD 0.6, 95% CI -0.2 to 1.4).
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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