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

NCT ID: NCT01708057

Last Updated: 2014-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2012-12-31

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).

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Single dose of AZD8683 50 µg

Group Type: EXPERIMENTAL

AZD8683

Intervention Type: DRUG

AZD8683 administered via inhalation

2

Single dose of AZD8683 150 µg

Group Type: EXPERIMENTAL

AZD8683

Intervention Type: DRUG

AZD8683 administered via inhalation

3

Single dose of AZD8683 300 µg

Group Type: EXPERIMENTAL

AZD8683

Intervention Type: DRUG

AZD8683 administered via inhalation

4

Single dose of AZD8683 900 µg

Group Type: EXPERIMENTAL

AZD8683

Intervention Type: DRUG

AZD8683 administered via inhalation

5

Single dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo administered via inhalation

6

Single dose of tiotropium 18 µg

Group Type: ACTIVE_COMPARATOR

Tiotropium

Intervention Type: DRUG

Tiotropium administered via inhalation

Interventions

AZD8683

AZD8683 administered via inhalation

Intervention Type: DRUG

Placebo

Placebo administered via inhalation

Intervention Type: DRUG

Tiotropium

Tiotropium administered via inhalation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carin Jorup, MD

Role: STUDY_DIRECTOR

AstraZeneca R&DMolndal, Sweden

Locations

Bialystok, , Poland

Lodz, , Poland

Proszowice, , Poland

Wroclaw, , Poland

Gothenburg, , Sweden

Lund, , Sweden

Countries

Poland; Sweden

Other Identifiers

EudraCT number: 2012-002900-42

Identifier Type: -

Identifier Source: secondary_id

D1883C00007

Identifier Type: -

Identifier Source: org_study_id