Navafenterol (AZD8871) in patients with mild asthma: a randomised placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of this novel inhaled long-acting dual-pharmacology bronchodilator.

ABSTRACT:

Background

Navafenterol (AZD8871) is an inhaled long-acting dual-pharmacology muscarinic antagonist/β₂-adrenoceptor agonist (MABA) in development for the treatment of obstructive airways diseases. The safety, tolerability, pharmacodynamics, and pharmacokinetics of navafenterol were investigated in patients with mild asthma.

Methods

This was a randomised, single-blind, placebo-controlled, single-ascending-dose study. Patients were randomly assigned to one of two cohorts which evaluated escalating doses of navafenterol (50-2100 μg) in an alternating manner over three treatment periods. The primary pharmacodynamic endpoint was the change from pre-dose baseline in trough forced expiratory volume in 1 s (FEV₁) for each treatment period.

Results

Sixtee

SUBMITTER: Jimenez E 

PROVIDER: S-EPMC7487994 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature