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
Outcome
Met primary endpoint
registry analysis (superiority test); AZD8871 vs Placebo; p <0.0001; Mean Difference (Final Values) 0.202 (95% CI 0.151 to 0.253); Mixed Models Analysis NCT03645434 ↗
registry analysis (superiority test); AZD8871 vs Placebo; p = 0.0022; Mean Difference (Final Values) -1.571 (95% CI -2.563 to -0.579); Mixed Models Analysis NCT03645434 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Umeclidinium | Other / unclassified | 55 ug | Inhaled |
| Subject | Vilanterol | Other / unclassified | 22 ug | Inhaled |
| Subject | navafenterol | Small molecule | 600 ug | Inhaled |