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NCT00076089 · ClinicalTrials.gov registry record · Phase 3

OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

A Phase 3 study of Chronic Obstructive Pulmonary Disease and COPD, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
1,100
Enrollment target
20
Study locations

NCT00076089 is a Phase 3 study of Chronic Obstructive Pulmonary Disease and COPD that has completed, run by AstraZeneca. The registered enrollment target is 1,100 participants, below the 1,741-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 20 states.

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The verdict

NCT00076089, a Phase 3 study of Chronic Obstructive Pulmonary Disease and COPD, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
1,100 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Interventions

  • DRUG Roflumilast

Study Locations (20)

Alabama

  • ALTANA Pharma - Cities in Alabama

Arizona

  • ALTANA Pharma - Cities in Arizona

Arkansas

  • ALTANA Pharma - Cities in Arkansas

California

  • ALTANA Pharma - Cities in California

Colorado

  • ALTANA Pharma - Cities in Colorado

Connecticut

  • ALTANA Pharma - Cities in Connecticut

Florida

  • ALTANA Pharma - Cities in Florida

Georgia

  • ALTANA Pharma - Cities in Georgia

Trial Details

FieldValue
Enrollment Target 1,100 participants
Start Date 2003-12
Est. Completion 2005-12
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT00076089

The ClinicalTrials.gov registry entry for NCT00076089 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,741-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (37% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 1 intervention - of which Roflumilast is the first listed.

NCT00076089 reports 20 study locations spanning 20 distinct geographic areas - top geographies include Alabama, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00076089 about?

NCT00076089 is a clinical study titled "OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)". The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

What is the current status of trial NCT00076089?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,100 participants. The study started on 2003-12. Estimated completion is 2005-12.

What conditions does trial NCT00076089 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease, COPD.

What interventions are being tested in trial NCT00076089?

The interventions under investigation include: Roflumilast (DRUG).

Who is sponsoring clinical trial NCT00076089?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00076089 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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