Effects of a Novel Dual Phosphodiesterase 3 and 4 Inhibitor TQC3721 in Patients with COPD in China (PACER-II): a phase 2, multicentre, randomised, double-blind, placebo-controlled trial - PubMed
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- TQC3721 is a novel inhaled dual PDE3 and PDE4 inhibitor with bronchodilator and anti-inflammatory effects.
- The PACER-II trial was a phase 2, randomized, double-blind, placebo-controlled study conducted at 27 centers in China.
- 240 COPD patients with post-bronchodilator FEV1 30-70% predicted and FEV1/FVC <0.7 were randomized to TQC3721 (3mg or 6mg) or placebo twice daily for 4 weeks.
- TQC3721 significantly improved peak FEV1 at week 4 compared to placebo (3mg: 100mL, P=0.0011; 6mg: 147mL, P<0.0001).
- The 6mg dose also improved average FEV1 AUC 0-12h (87mL, P<0.0001) and symptoms (SGRQ -5.09, P=0.0031).
- Improvements were significant in both LAMA and LABA/LAMA subgroups.
- TQC3721 had a safety profile similar to placebo.
- The study supports further development of TQC3721 for COPD treatment.