From the FDA Drug Label
The efficacy of OHTUVAYRE was evaluated in two 24-week randomized, double-blind, placebo-controlled, parallel-group clinical trials (ENHANCE-1 [NCT04535986] and ENHANCE-2 [NCT04542057]). The two trials enrolled a total of 1553 adults with moderate to severe COPD ENHANCE-1 enrolled a total of 763 patients randomized 5:3 to receive 3 mg of OHTUVAYRE administered by oral inhalation via standard jet nebulizer such as PARI LC Sprint® [see Description (11)], or placebo. ENHANCE-2 enrolled a total of 790 patients randomized 5:3 to receive 3 mg of OHTUVAYRE twice daily administered by oral inhalation via a standard jet nebulizer such as PARI LC Sprint [see Description (11)] or placebo.
The trials that involve ensifentrine are:
- ENHANCE-1 [NCT04535986]
- ENHANCE-2 [NCT04542057] 1
From the Research
Ensifentrine has been evaluated in several clinical trials, most notably the Phase 3 ENHANCE program, which includes two studies (ENHANCE-1 and ENHANCE-2) that demonstrated its efficacy and safety in patients with chronic obstructive pulmonary disease (COPD) 2.
Key Findings
- The ENHANCE trials showed that ensifentrine, a dual phosphodiesterase (PDE) 3 and 4 inhibitor delivered via nebulizer, significantly improved lung function and reduced symptoms in COPD patients.
- The typical dosage studied was 3 mg administered twice daily via nebulizer.
- Ensifentrine has also been investigated in earlier phase trials for cystic fibrosis and asthma.
- The medication works through a novel mechanism that combines bronchodilation and anti-inflammatory effects by inhibiting both PDE3 and PDE4 enzymes, making it potentially valuable for patients who don't respond adequately to current standard treatments.
Trial Overview
- The ENHANCE-1 and ENHANCE-2 trials were randomized, double-blind, placebo-controlled, multicenter Phase III trials that assessed the efficacy and safety of ensifentrine in patients with moderate to severe COPD 2.
- A pooled analysis of the ENHANCE trials demonstrated that ensifentrine reduced the rate and risk of moderate to severe exacerbations compared to placebo 3.
- Ensifentrine has also been shown to improve symptoms and quality of life in patients with COPD, with a notable effect on dyspnea 4.
Recommendations
- Based on the most recent and highest quality evidence, ensifentrine is a promising treatment option for patients with COPD, particularly those who do not respond adequately to current standard treatments 2, 3.
- Ensifentrine may be considered as a monotherapy or as an add-on to existing treatments, and its efficacy and safety have been demonstrated in patients with moderate to severe COPD.