A Single Inhalation Dose Study to Assess Efficacy, Pharmacokinetics (PK), Safety and Tolerability of AZD8871 in Patients With Long-term Lung Diseases.

Summary

This study will evaluate the efficacy and safety data of AZD8871 in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will determine the 24-hour efficacy (lung function) profile of AZD8871 600 μg relative to placebo dry powder inhaler (DPI) based on trough forced expiratory volume in 1 second (FEV1) following repeated dosing (2 weeks). Anoro® Ellipta® (umeclidinium/vilanterol) once daily is included as an active control. This study aims at providing a novel approach to the treatment of COPD with greater efficacy than single-mechanism bronchodilators, equivalent to long-acting muscarinic antagonist (LAMA) and long-acting β2-agonist (LABA) administered as free- or fixed-dose combination therapies, with an equivalent or superior safety and tolerability profile.

Timeline

Start

2018-10-10

Primary completion

2019-08-07

Completion

2019-08-07

Publications

• Singh D, Beier J, Astbury C, Belvisi MG, Da Silva CA, Jauhiainen A, Jimenez E, Lei A, Necander S, Smith JA, Wahlby Hamren U, Xin W, Psallidas I. The novel bronchodilator navafenterol: a phase 2a, multicentre, randomised, double-blind, placebo-controlled crossover trial in COPD. Eur Respir J. 2022 Apr 7;59(4):2100972. doi: 10.1183/13993003.00972-2021. Print 2022 Apr.

Drugs

Indications