Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

NCT ID: NCT00062582

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Brief Summary

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The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease COPD

Keywords

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Roflumilast Chronic Obstructive Pulmonary Disease COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Roflumilast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)
* Currently stable COPD with no change in COPD treatment in the prior 4 weeks

Exclusion Criteria

* Clinical diagnosis of asthma
* Poorly controlled COPD
* Regular need for daily oxygen therapy
Minimum Eligible Age

18 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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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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ALTANA Pharma

Cities in Alabama, Alabama, United States

Site Status

ALTANA Pharma

Cities in Arizona, Arizona, United States

Site Status

ALTANA Pharma

Cities in California, California, United States

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ATLANA Pharma

Cities in Colorado, Colorado, United States

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ALTANA Pharma

Cities in Conneticut, Connecticut, United States

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ALTANA Pharma

Cities in Delaware, Delaware, United States

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ALTANA Pharma

Cities in Florida, Florida, United States

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ALTANA Pharma

Cities in Georgia, Georgia, United States

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ALTANA Pharma

Cities in Idaho, Idaho, United States

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ALTANA Pharma

Cities in Indiana, Indiana, United States

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ALTANA Pharma

Cities in Iowa, Iowa, United States

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ALTANA Pharma

Cities in Kansas, Kansas, United States

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ALTANA Pharma

Cities in Kentucky, Kentucky, United States

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ALTANA Pharma

Cities in Louisiana, Louisiana, United States

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ALTANA Pharma

Cities in Maryland, Maryland, United States

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ALTANA Pharma

Cities in Michigan, Michigan, United States

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ALTANA Pharma

Cities in Missouri, Missouri, United States

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ALTANA Pharma

Cities in Nebraska, Nebraska, United States

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ALTANA Pharma

Cities in Nevada, Nevada, United States

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ALTANA Pharma

Cities in New Jersey, New Jersey, United States

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ALTANA Pharma

Cities in New York, New York, United States

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ALTANA Pharma

Cities in North Carolina, North Carolina, United States

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ALTANA Pharma

Cities in Ohio, Ohio, United States

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ALTANA Pharma

Cities in Oregon, Oregon, United States

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ALTANA Pharma

Cities in Pennsylvania, Pennsylvania, United States

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ALTANA Pharma

Cities in Rhode Island, Rhode Island, United States

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ALTANA Pharma

Cities in South Carolina, South Carolina, United States

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ALTANA Pharma

Cities in Texas, Texas, United States

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ALTANA Pharma

Cities in Utah, Utah, United States

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ALTANA Pharma

Cities in Virginia, Virginia, United States

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ALTANA Pharma

Cities in Washington, Washington, United States

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ALTANA Pharma

Cities in West Virginia, West Virginia, United States

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ALTANA Pharma

Cities in Argentina, , Argentina

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ALTANA Pharma

Cities in Canada, , Canada

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ALTANA Pharma

Cities in Colombia, , Colombia

Site Status

ALTANA Pharma

Cities in Mexico, , Mexico

Site Status

ALTANA Pharma

Cities in Peru, , Peru

Site Status

Countries

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United States Argentina Canada Colombia Mexico Peru

Related Links

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Other Identifiers

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BY217/M2-110

Identifier Type: -

Identifier Source: org_study_id