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

NCT ID: NCT01205269

Last Updated: 2014-03-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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)

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

AZD8683, 50 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

Placebo

Intervention Type DRUG

Dry powder for inhalation, single dose

AZD8683, 200 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

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

Group Type EXPERIMENTAL

AZD8683, 50 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

Placebo

Intervention Type DRUG

Dry powder for inhalation, single dose

AZD8683, 200 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

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

Group Type EXPERIMENTAL

AZD8683, 50 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

Placebo

Intervention Type DRUG

Dry powder for inhalation, single dose

AZD8683, 200 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

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

Group Type EXPERIMENTAL

AZD8683, 50 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

Placebo

Intervention Type DRUG

Dry powder for inhalation, single dose

AZD8683, 200 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

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

Group Type EXPERIMENTAL

AZD8683, 50 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

Placebo

Intervention Type DRUG

Dry powder for inhalation, single dose

AZD8683, 200 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

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

Group Type EXPERIMENTAL

AZD8683, 50 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

Placebo

Intervention Type DRUG

Dry powder for inhalation, single dose

AZD8683, 200 mcg

Intervention Type DRUG

Dry powder for inhalation, single dose

Interventions

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AZD8683, 50 mcg

Dry powder for inhalation, single dose

Intervention Type DRUG

Placebo

Dry powder for inhalation, single dose

Intervention Type DRUG

AZD8683, 200 mcg

Dry powder for inhalation, single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Piotr Kuna, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Poland

Locations

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Research Site

Bialystok, , Poland

Site Status

Research Site

Bydgoszcz, , Poland

Site Status

Research Site

Lodz, , Poland

Site Status

Research Site

Proszowice, , Poland

Site Status

Countries

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Poland

Other Identifiers

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EudraCT number: 2010-020506-15

Identifier Type: -

Identifier Source: secondary_id

D1883C00004

Identifier Type: -

Identifier Source: org_study_id

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