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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205269
• Other study ID #: D1883C00004
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2010
• Last updated: February 24, 2014
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD8683, 50 mcg
Dry powder for inhalation, single dose
• Placebo
Dry powder for inhalation, single dose
• AZD8683, 200 mcg
Dry powder for inhalation, single dose

Locations

Country	Name	City	State
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Lódz
Poland	Research Site	Proszowice

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose	Trough FEV1 value	22 h, 24 h, 26 h	No
Secondary	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	No
Secondary	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	No
Secondary	Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose	Average systolic blood pressure value	0, 30 min, 2 h, 4 h	No
Secondary	Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose	Average diastolic blood pressure value	0, 30 min, 2 h, 4 h	No
Secondary	Pulse, Average Effect Over 0 - 4 Hours Post-dose	Average pulse value	0, 30 min, 2 h, 4 h	No
Secondary	Heart Rate, Average Effect Over 0 - 4 Hours Post-dose	Average heart rate value	0, 30 min, 2 h, 4 h	No
Secondary	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	No
Secondary	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	No
Secondary	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	No