The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Placebo; Drug: AZD8683, 50 mcg; Drug: AZD8683, 200 mcg

Detailed Description

A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland
    • Research Site
  • Bydgoszcz, Poland
    • Research Site
  • Proszowice, Poland
    • Research Site
  • Łódź, Poland
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of COPD
• Current or ex-smokers
• FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70%

Exclusion Criteria:

• Any clinically significant disease or disorder
• Any clinically relevant abnormal findings at screening examinations
• Family history or presence of glaucoma
• Need of long term oxygen therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First 50 mcg, then 200 mcg, then placebo; period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo	Drug: Placebo; Dry powder for inhalation, single dose; Drug: AZD8683, 50 mcg; Dry powder for inhalation, single dose; Drug: AZD8683, 200 mcg; Dry powder for inhalation, single dose
Experimental: First 50 mcg, then placebo, then 200 mcg; period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg	Drug: Placebo; Dry powder for inhalation, single dose; Drug: AZD8683, 50 mcg; Dry powder for inhalation, single dose; Drug: AZD8683, 200 mcg; Dry powder for inhalation, single dose
Experimental: First 200 mcg, then placebo, then 50 mcg; period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg	Drug: Placebo; Dry powder for inhalation, single dose; Drug: AZD8683, 50 mcg; Dry powder for inhalation, single dose; Drug: AZD8683, 200 mcg; Dry powder for inhalation, single dose
Experimental: First 200 mcg, then 50 mcg, then placebo; period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo	Drug: Placebo; Dry powder for inhalation, single dose; Drug: AZD8683, 50 mcg; Dry powder for inhalation, single dose; Drug: AZD8683, 200 mcg; Dry powder for inhalation, single dose
Experimental: First placebo, then 200 mcg, then 50 mcg; period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg	Drug: Placebo; Dry powder for inhalation, single dose; Drug: AZD8683, 50 mcg; Dry powder for inhalation, single dose; Drug: AZD8683, 200 mcg; Dry powder for inhalation, single dose
Experimental: First placebo, then 50 mcg, then 200 mcg; period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg	Drug: Placebo; Dry powder for inhalation, single dose; Drug: AZD8683, 50 mcg; Dry powder for inhalation, single dose; Drug: AZD8683, 200 mcg; Dry powder for inhalation, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose	Trough FEV1 value	22 h, 24 h, 26 h
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose	Maximum FEV1 value	0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose	Average systolic blood pressure value	0, 30 min, 2 h, 4 h
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose	Average diastolic blood pressure value	0, 30 min, 2 h, 4 h
Pulse, Average Effect Over 0 - 4 Hours Post-dose	Average pulse value	0, 30 min, 2 h, 4 h
Heart Rate, Average Effect Over 0 - 4 Hours Post-dose	Average heart rate value	0, 30 min, 2 h, 4 h
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose	Average FEV1 value	0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose	Maximum FVC value	0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
QTcF, Average Effect Over 0 - 4 Hours Post-dose	Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula	0, 30 min, 2 h, 4 h
Plasma AZD8683 Cmax	Maximum plasma concentration of AZD8683	0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
Plasma AZD8683 AUC0-24	Area under the AZD8683 plasma concentration curve from 0 to 24 hours	0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Piotr Kuna, MD Professor, Poland

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: September 17, 2010
• First Posted (Estimate): September 20, 2010

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: February 24, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: safety; inhalation; Chronic Obstructive Pulmonary Disease (COPD); long-acting muscarinic receptor antagonist (LAMA)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D1883C00004; EudraCT number: 2010-020506-15