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

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AZD8683

Placebo

Tiotropium

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Chronic obstructive pulmonary disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Single dose of AZD8683 50 µg

Single dose of AZD8683 150 µg

Single dose of AZD8683 300 µg

Single dose of AZD8683 900 µg

Single dose of placebo

Single dose of tiotropium 18 µg

Outcomes

Primary Outcome Measures

Change From Baseline in Peak FEV1 (0-24h)

The maximum value over 24 hours post-dose, as change from baseline

Change From Baseline in Trough FEV1 (22-26h)

The average over 22 to 26 hours, as change from baseline

Secondary Outcome Measures

Average FEV1 as a Change From Baseline

Average FEV1 (0-24h): The average over 0 to 24 hours

Maximum Increase in Systolic Blood Pressure [SBP]

Maximum (post-dose values - baseline value) for each treatment visit.

Maximum Increase in Diastolic Blood Pressure [DBP]

Maximum (post-dose values - baseline value) for each treatment visit.

Maximum Increase Heart Rate [HR]

Maximum (post-dose values - baseline value) for each treatment visit.

Maximum Increase in QTcF

maximum (post-dose values - baseline value) for each treatment visit.

PK Parameters (AZD8683)

Cmax, tmax, AUC

Full Information

NCT ID

NCT01708057

First Posted

October 1, 2012

Last Updated

December 13, 2013

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01708057

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Terminated

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, COPD

Keywords

COPD, Chronic obstructive pulmonary disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Single dose of AZD8683 50 µg

Arm Title

Arm Type

Experimental

Arm Description

Single dose of AZD8683 150 µg

Arm Title

Arm Type

Experimental

Arm Description

Single dose of AZD8683 300 µg

Arm Title

Arm Type

Experimental

Arm Description

Single dose of AZD8683 900 µg

Arm Title

Arm Type

Placebo Comparator

Arm Description

Single dose of placebo

Arm Title

Arm Type

Active Comparator

Arm Description

Single dose of tiotropium 18 µg

Intervention Type

Drug

Intervention Name(s)

AZD8683

Intervention Description

AZD8683 administered via inhalation

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo administered via inhalation

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

Tiotropium administered via inhalation

Primary Outcome Measure Information:

Title

Change From Baseline in Peak FEV1 (0-24h)

Description

The maximum value over 24 hours post-dose, as change from baseline

Time Frame

The first 24 hours following dose administration

Title

Change From Baseline in Trough FEV1 (22-26h)

Description

The average over 22 to 26 hours, as change from baseline

Time Frame

22 to 26 hours following dose administration

Secondary Outcome Measure Information:

Title

Average FEV1 as a Change From Baseline

Description

Average FEV1 (0-24h): The average over 0 to 24 hours

Time Frame

The first 24 hours following dose administration

Title

Maximum Increase in Systolic Blood Pressure [SBP]

Description

Maximum (post-dose values - baseline value) for each treatment visit.

Time Frame

baseline, 24hr post dose

Title

Maximum Increase in Diastolic Blood Pressure [DBP]

Description

Maximum (post-dose values - baseline value) for each treatment visit.

Time Frame

The first 24 hours following dose administration

Title

Maximum Increase Heart Rate [HR]

Description

Maximum (post-dose values - baseline value) for each treatment visit.

Time Frame

baseline, 24hr post dose

Title

Maximum Increase in QTcF

Description

maximum (post-dose values - baseline value) for each treatment visit.

Time Frame

baseline, 24hr post dose

Title

PK Parameters (AZD8683)

Description

Cmax, tmax, AUC

Time Frame

Pre-dose, 24hr post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carin Jorup, MD

Organizational Affiliation

AstraZeneca R&DMolndal, Sweden

Official's Role

Study Director

Facility Information:

City

Bialystok

Country

Poland

City

Lodz

Country

Poland

City

Proszowice

Country

Poland

City

Wroclaw

Country

Poland

City

Goteborg

Country

Sweden

City

Lund

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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