A Phase IIa, Randomised, Multi-Centre, Double-Blind, Placebo-Controlled, 3 Periods, Crossover Study to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Inhaled AZD8871 Administered once daily for 2 Weeks in Patients with Moderate to Severe COPD.
Chronic Obstructive Pulmonary Disease COPD
AZD8871 100 µg, AZD8871 600 µg, Placebo
40 Years - 80 Years
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jun 2019 by AstraZeneca
No locations available
|Experimental: AZD8871 100 µg
The subjects will receive AZD8871 100 µg once daily, by dry powder inhaler (DPI) device. The treatment will be administered via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.
Drug: AZD8871 100 µg
The subjects will receive one dose of AZD8871 100 µg single dose DPI.
|Placebo Comparator: Placebo
The placebo will be administered via single dose DPI that is an adaptation of the commercially available Genuair® with a smaller internal volume to enable delivery of single doses. To maintain blinding, each patient will receive one inhaled dose from placebo DPI provided to him/her on each day of the treatment period.
The subject will receive Placebo single dose DPI.
|Experimental: AZD8871 600 µg
The subjects will receive AZD8871 600 µg once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.
Drug: AZD8871 600 µg
The subjects will receive AZD8871, 600 µg single dose DPI.