A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Phase 2

Terminated

Brief Summary: This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.

Detailed Description: A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Recruitment & Eligibility

Inclusion Criteria

Provision of informed consent prior to any study specific procedures Male or female, age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue until follow-up
Clinical diagnosis of COPD for more than 1 year at Visit 1
FEV1 ≥ 30 to < 80% of the predicted normal value (post-bronchodilator) at Visit 2 and post-bronchodilator FEV1/FVC < 70%
Reversible airway obstruction

Exclusion Criteria

Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS) and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or during the enrolment period
Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period
Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged by the Investigator
Long-term oxygen therapy, as judged by the Investigator

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Peak FEV1 (0-24h)	The first 24 hours following dose administration	The maximum value over 24 hours post-dose, as change from baseline
Change From Baseline in Trough FEV1 (22-26h)	22 to 26 hours following dose administration	The average over 22 to 26 hours, as change from baseline

Secondary Outcome Measures

Name	Time	Method
Maximum Increase in Systolic Blood Pressure [SBP]	baseline, 24hr post dose	Maximum (post-dose values - baseline value) for each treatment visit.
PK Parameters (AZD8683)	Pre-dose, 24hr post-dose	Cmax, tmax, AUC
Average FEV1 as a Change From Baseline	The first 24 hours following dose administration	Average FEV1 (0-24h): The average over 0 to 24 hours
Maximum Increase in Diastolic Blood Pressure [DBP]	The first 24 hours following dose administration	Maximum (post-dose values - baseline value) for each treatment visit.
Maximum Increase Heart Rate [HR]	baseline, 24hr post dose	Maximum (post-dose values - baseline value) for each treatment visit.
Maximum Increase in QTcF	baseline, 24hr post dose	maximum (post-dose values - baseline value) for each treatment visit.