This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation. There are 7 in-clinic visits over a total duration of up to 24 weeks participation.
None
None
Crossover
Ensifentrine
DrugEnsifentrine twice daily administered with jet nebulizer for 8 weeks
Placebo
DrugPlacebo ensifentrine twice daily administered with jet nebulizer for 8 weeks
The change from baseline in sputum neutrophils at Week 8 (absolute change in cell numbers)
To measure the effect of nebulized ensifentrine on sputum absolute neutrophil count after twice daily dosing.
The change from baseline in sputum cell counts at Week 8 (absolute change in cell numbers)
To measure the effect of nebulized ensifentrine on sputum absolute change in cell numbers (e.g., eosinophils, basophils, macrophages, lymphocytes, total cells) in subjects with COPD during the treatment period
The percent change from baseline in sputum cell counts at Week 8
To measure the effect of nebulized ensifentrine on sputum markers of inflammation (e.g., neutrophils, eosinophils, basophils, macrophages, lymphocytes, and total cells) after twice daily dosing.
The percent change from baseline in sputum markers of inflammation at Week 8
To measure the effect of nebulized ensifentrine on sputum markers of inflammation ( cytokines, proteases) after twice daily dosing. Analytes for sputum analyses will be described in the SAP.
The change from baseline in FEV1 after 4 weeks
To measure the effect of nebulized ensifentrine on lung function during the treatment period (pre-dose and 2 hours post-dose).
Exploratory: change from baseline in blood markers of inflammation after 4 weeks
The change from baseline in absolute blood cell counts, cytokines, proteases, and markers of inflammation during the treatment period. Analytes and timepoints for exploratory blood analyses will be described in the SAP.
Exploratory: change from baseline in blood markers of inflammation after 8 weeks
The change from baseline in absolute blood cell counts, cytokines, proteases, and markers of inflammation during the treatment period. Analytes and timepoints for exploratory blood analyses will be described in the SAP.
Exploratory: The percent change from baseline in sputum AcPGP at week 8
To measure the effect of nebulized ensifentrine on sputum AcPGP and PGP levels in subjects with COPD during the treatment period
Exploratory: The percent change from baseline in sputum PGP at week 8
To measure the effect of nebulized ensifentrine on sputum AcPGP and PGP levels in subjects with COPD during the treatment period
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Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
Lead sponsor
University of Alabama at Birmingham
Collaborator
