Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study.

ABSTRACT:

Background

This study evaluated the efficacy, safety and tolerability of the novel inhaled phosphodiesterase-4 inhibitor CHF6001 added-on to formoterol in patients with chronic obstructive pulmonary disease (COPD).

Methods

Randomised, double-blind, placebo- and active-controlled, parallel-group study. Eligible patients had symptomatic COPD, post-bronchodilator forced expiratory volume in 1 s (FEV₁) 30-70% predicted, and history of ≥1 moderate/severe exacerbation. Patients were randomised to extrafine CHF6001 400, 800, 1200 or 1600 μg twice daily (BID), budesonide, or placebo for 24 weeks.

Primary objectives

To investigate CHF6001 dose-response for pre-dose FEV₁ after 12 weeks, and to identify the optimal dose. Moderate-to-severe exacerbations wer

SUBMITTER: Singh D 

PROVIDER: S-EPMC7510119 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature