The study will evaluate the effect of AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD)

Study identifier:D1883C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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)

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

Study drug

AZD8683, 50 mcg, Placebo, AZD8683, 200 mcg

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Oct 2010

Primary Completion Date: 01 Dec 2010

Study Completion Date: 01 Dec 2010

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2013 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Białystok, Poland

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Łódź, Poland

Location

Research Site

Proszowice, Poland

Arms	Assigned Interventions
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: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo 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: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo 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: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo 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: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo 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: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo 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: AZD8683, 50 mcg Dry powder for inhalation, single dose Drug: Placebo Dry powder for inhalation, single dose Drug: AZD8683, 200 mcg Dry powder for inhalation, single dose

Documents available

D1883C00004 Clinical Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Piotr Kuna

Poland

The study will evaluate the effect of AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Documents available

D1883C00004 Clinical Report Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator