A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

This is a Phase IIb, randomized, parallel group study comparing efficacy and safety of two fixed dose nebulizer combinations of ensifentrine (PDE3/4 inhibitor) and glycopyrrolate  (anticholinergic) vs ensifentrine monotherapy, glycopyrrolate monotherapy, or placebo in adult patients with COPD. These will be each administered twice a day via standard jet nebulizer.

Primary End-Points:
  • Change from baseline in FEV1 AUC 0-4 hrs
Ensifentrine-glycopyrrolate
Key inclusion criteria are:
  • COPD with FEV1 30 - 70% 
  • Not taking long acting anticholinergic for at least 60 days..
  • On no maintenance therapy OR on LABA or ICS/LABA inhaled therapy
  • Current or former smoker
ClinicalTrials.gov Identifier: NCT07016412

For more detailed information on this trial please click the link above to visit ClinicalTrials.gov

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