NCT00062582

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
6 countries

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2003

Completed
Last Updated

November 23, 2016

Status Verified

September 1, 2016

First QC Date

June 9, 2003

Last Update Submit

November 22, 2016

Conditions

Chronic Obstructive Pulmonary DiseaseCOPD

Keywords

RoflumilastChronic Obstructive Pulmonary DiseaseCOPD

Outcome Measures

Primary Outcomes (1)

  • pulmonary function.

Secondary Outcomes (5)

  • exacerbation rate

  • quality of life

  • symptoms

  • use of rescue medication

  • safety and tolerability.

Interventions

RoflumilastDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Clinical diagnosis of asthma
  • Poorly controlled COPD
  • Regular need for daily oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

ALTANA Pharma

Cities in Alabama, Alabama, United States

Location

ALTANA Pharma

Cities in Arizona, Arizona, United States

Location

ALTANA Pharma

Cities in California, California, United States

Location

ATLANA Pharma

Cities in Colorado, Colorado, United States

Location

ALTANA Pharma

Cities in Conneticut, Connecticut, United States

Location

ALTANA Pharma

Cities in Delaware, Delaware, United States

Location

ALTANA Pharma

Cities in Florida, Florida, United States

Location

ALTANA Pharma

Cities in Georgia, Georgia, United States

Location

ALTANA Pharma

Cities in Idaho, Idaho, United States

Location

ALTANA Pharma

Cities in Indiana, Indiana, United States

Location

ALTANA Pharma

Cities in Iowa, Iowa, United States

Location

ALTANA Pharma

Cities in Kansas, Kansas, United States

Location

ALTANA Pharma

Cities in Kentucky, Kentucky, United States

Location

ALTANA Pharma

Cities in Louisiana, Louisiana, United States

Location

ALTANA Pharma

Cities in Maryland, Maryland, United States

Location

ALTANA Pharma

Cities in Michigan, Michigan, United States

Location

ALTANA Pharma

Cities in Missouri, Missouri, United States

Location

ALTANA Pharma

Cities in Nebraska, Nebraska, United States

Location

ALTANA Pharma

Cities in Nevada, Nevada, United States

Location

ALTANA Pharma

Cities in New Jersey, New Jersey, United States

Location

ALTANA Pharma

Cities in New York, New York, United States

Location

ALTANA Pharma

Cities in North Carolina, North Carolina, United States

Location

ALTANA Pharma

Cities in Ohio, Ohio, United States

Location

ALTANA Pharma

Cities in Oregon, Oregon, United States

Location

ALTANA Pharma

Cities in Pennsylvania, Pennsylvania, United States

Location

ALTANA Pharma

Cities in Rhode Island, Rhode Island, United States

Location

ALTANA Pharma

Cities in South Carolina, South Carolina, United States

Location

ALTANA Pharma

Cities in Texas, Texas, United States

Location

ALTANA Pharma

Cities in Utah, Utah, United States

Location

ALTANA Pharma

Cities in Virginia, Virginia, United States

Location

ALTANA Pharma

Cities in Washington, Washington, United States

Location

ALTANA Pharma

Cities in West Virginia, West Virginia, United States

Location

ALTANA Pharma

Cities in Argentina, Argentina

Location

ALTANA Pharma

Cities in Canada, Canada

Location

ALTANA Pharma

Cities in Colombia, Colombia

Location

ALTANA Pharma

Cities in Mexico, Mexico

Location

ALTANA Pharma

Cities in Peru, Peru

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2003

First Posted

June 10, 2003

Study Start

June 1, 2003

Last Updated

November 23, 2016

Record last verified: 2016-09

Locations

US(32)AR(1)PE(1)CA(1)CO(1)ME(1)