The novel inhaled dual PDE3 and PDE4 inhibitor ensifentrine for the treatment of COPD: A systematic review and meta-analysis protocol on trough FEV1 and exacerbation according to PRISMA statement

The investigation of ensifentrine, an inhaled dual phosphodiesterase (PDE)3 and PDE4 inhibitor, for chronic obstructive pulmonary disease (COPD) maintenance therapy presents a significant clinical interest. Despite promising results from recent Phase III trials, a comprehensive synthesis of its ther...

Full description

Saved in:
Bibliographic Details
Main Authors: Luigino Calzetta, Mario Cazzola, Shima Gholamalishahi, Paola Rogliani
Format: Article
Language:English
Published: Elsevier 2024-01-01
Series:Current Research in Pharmacology and Drug Discovery
Online Access:http://www.sciencedirect.com/science/article/pii/S2590257124000221
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1846123380721319936
author Luigino Calzetta
Mario Cazzola
Shima Gholamalishahi
Paola Rogliani
author_facet Luigino Calzetta
Mario Cazzola
Shima Gholamalishahi
Paola Rogliani
author_sort Luigino Calzetta
collection DOAJ
description The investigation of ensifentrine, an inhaled dual phosphodiesterase (PDE)3 and PDE4 inhibitor, for chronic obstructive pulmonary disease (COPD) maintenance therapy presents a significant clinical interest. Despite promising results from recent Phase III trials, a comprehensive synthesis of its therapeutic efficacy in COPD is lacking. This protocol outlines the first registered systematic review and meta-analysis in PROSPERO to assess the impact of ensifentrine on trough forced expiratory volume in the 1st second (FEV1) and acute exacerbations of COPD. By conducting a rigorous literature search and employing solid methodologies, this endeavour aims to provide robust evidence on the real efficacy of ensifentrine. Anticipated outcomes include a significant improvement in trough FEV1 and a reduction in AECOPD risk among ensifentrine-treated patients compared to controls, corroborating its bronchodilator and anti-inflammatory properties. The meta-analysis expects to reveal consistent results across different trials, enhancing confidence in the findings. Additionally, subgroup analyses may unveil factors influencing the efficacy of ensifentrine, guiding optimal therapeutic strategies. Overall, this protocol holds the potential to inform clinical practice and regulatory decisions, positioning ensifentrine as a valuable addition to COPD management.
format Article
id doaj-art-fa1684766cc34009b4e9ee416809ddf0
institution Kabale University
issn 2590-2571
language English
publishDate 2024-01-01
publisher Elsevier
record_format Article
series Current Research in Pharmacology and Drug Discovery
spelling doaj-art-fa1684766cc34009b4e9ee416809ddf02024-12-14T06:32:46ZengElsevierCurrent Research in Pharmacology and Drug Discovery2590-25712024-01-017100195The novel inhaled dual PDE3 and PDE4 inhibitor ensifentrine for the treatment of COPD: A systematic review and meta-analysis protocol on trough FEV1 and exacerbation according to PRISMA statementLuigino Calzetta0Mario Cazzola1Shima Gholamalishahi2Paola Rogliani3Department of Medicine and Surgery, Respiratory Disease and Lung Function Unit, University of Parma, Parma, Italy; Corresponding author. Respiratory Disease and Lung Function Unit, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, 43126 Parma, Italy.Department of Experimental Medicine, Unit of Respiratory Medicine, University of Rome “Tor Vergata”, Rome, ItalyDepartment of Experimental Medicine, Unit of Respiratory Medicine, University of Rome “Tor Vergata”, Rome, ItalyDepartment of Experimental Medicine, Unit of Respiratory Medicine, University of Rome “Tor Vergata”, Rome, ItalyThe investigation of ensifentrine, an inhaled dual phosphodiesterase (PDE)3 and PDE4 inhibitor, for chronic obstructive pulmonary disease (COPD) maintenance therapy presents a significant clinical interest. Despite promising results from recent Phase III trials, a comprehensive synthesis of its therapeutic efficacy in COPD is lacking. This protocol outlines the first registered systematic review and meta-analysis in PROSPERO to assess the impact of ensifentrine on trough forced expiratory volume in the 1st second (FEV1) and acute exacerbations of COPD. By conducting a rigorous literature search and employing solid methodologies, this endeavour aims to provide robust evidence on the real efficacy of ensifentrine. Anticipated outcomes include a significant improvement in trough FEV1 and a reduction in AECOPD risk among ensifentrine-treated patients compared to controls, corroborating its bronchodilator and anti-inflammatory properties. The meta-analysis expects to reveal consistent results across different trials, enhancing confidence in the findings. Additionally, subgroup analyses may unveil factors influencing the efficacy of ensifentrine, guiding optimal therapeutic strategies. Overall, this protocol holds the potential to inform clinical practice and regulatory decisions, positioning ensifentrine as a valuable addition to COPD management.http://www.sciencedirect.com/science/article/pii/S2590257124000221
spellingShingle Luigino Calzetta
Mario Cazzola
Shima Gholamalishahi
Paola Rogliani
The novel inhaled dual PDE3 and PDE4 inhibitor ensifentrine for the treatment of COPD: A systematic review and meta-analysis protocol on trough FEV1 and exacerbation according to PRISMA statement
Current Research in Pharmacology and Drug Discovery
title The novel inhaled dual PDE3 and PDE4 inhibitor ensifentrine for the treatment of COPD: A systematic review and meta-analysis protocol on trough FEV1 and exacerbation according to PRISMA statement
title_full The novel inhaled dual PDE3 and PDE4 inhibitor ensifentrine for the treatment of COPD: A systematic review and meta-analysis protocol on trough FEV1 and exacerbation according to PRISMA statement
title_fullStr The novel inhaled dual PDE3 and PDE4 inhibitor ensifentrine for the treatment of COPD: A systematic review and meta-analysis protocol on trough FEV1 and exacerbation according to PRISMA statement
title_full_unstemmed The novel inhaled dual PDE3 and PDE4 inhibitor ensifentrine for the treatment of COPD: A systematic review and meta-analysis protocol on trough FEV1 and exacerbation according to PRISMA statement
title_short The novel inhaled dual PDE3 and PDE4 inhibitor ensifentrine for the treatment of COPD: A systematic review and meta-analysis protocol on trough FEV1 and exacerbation according to PRISMA statement
title_sort novel inhaled dual pde3 and pde4 inhibitor ensifentrine for the treatment of copd a systematic review and meta analysis protocol on trough fev1 and exacerbation according to prisma statement
url http://www.sciencedirect.com/science/article/pii/S2590257124000221
work_keys_str_mv AT luiginocalzetta thenovelinhaleddualpde3andpde4inhibitorensifentrineforthetreatmentofcopdasystematicreviewandmetaanalysisprotocolontroughfev1andexacerbationaccordingtoprismastatement
AT mariocazzola thenovelinhaleddualpde3andpde4inhibitorensifentrineforthetreatmentofcopdasystematicreviewandmetaanalysisprotocolontroughfev1andexacerbationaccordingtoprismastatement
AT shimagholamalishahi thenovelinhaleddualpde3andpde4inhibitorensifentrineforthetreatmentofcopdasystematicreviewandmetaanalysisprotocolontroughfev1andexacerbationaccordingtoprismastatement
AT paolarogliani thenovelinhaleddualpde3andpde4inhibitorensifentrineforthetreatmentofcopdasystematicreviewandmetaanalysisprotocolontroughfev1andexacerbationaccordingtoprismastatement
AT luiginocalzetta novelinhaleddualpde3andpde4inhibitorensifentrineforthetreatmentofcopdasystematicreviewandmetaanalysisprotocolontroughfev1andexacerbationaccordingtoprismastatement
AT mariocazzola novelinhaleddualpde3andpde4inhibitorensifentrineforthetreatmentofcopdasystematicreviewandmetaanalysisprotocolontroughfev1andexacerbationaccordingtoprismastatement
AT shimagholamalishahi novelinhaleddualpde3andpde4inhibitorensifentrineforthetreatmentofcopdasystematicreviewandmetaanalysisprotocolontroughfev1andexacerbationaccordingtoprismastatement
AT paolarogliani novelinhaleddualpde3andpde4inhibitorensifentrineforthetreatmentofcopdasystematicreviewandmetaanalysisprotocolontroughfev1andexacerbationaccordingtoprismastatement