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

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Treatments: Drug: Tiotropium; Drug: AZD8683; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01708057

D1883C00007

EudraCT number: 2012-002900-42

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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3 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

Single dose of AZD8683 50 µg

Treatment:

Drug: AZD8683

2

Experimental group

Description:

Single dose of AZD8683 150 µg

Treatment:

Drug: AZD8683

3

Experimental group

Description:

Single dose of AZD8683 300 µg

Treatment:

Drug: AZD8683

4

Experimental group

Description:

Single dose of AZD8683 900 µg

Treatment:

Drug: AZD8683

5

Placebo Comparator group

Description:

Single dose of placebo

Treatment:

Drug: Placebo

6

Active Comparator group

Description:

Single dose of tiotropium 18 µg

Treatment:

Drug: Tiotropium