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

A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Sponsoren

Hauptsponsor: AstraZeneca

Quelle AstraZeneca
Kurze Zusammenfassung

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

Gesamtstatus Completed
Anfangsdatum June 2003
Phase Phase 3
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
pulmonary function.
Sekundäres Ergebnis
Messen Zeitfenster
exacerbation rate
quality of life
symptoms
use of rescue medication
safety and tolerability.
Einschreibung 1000
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Roflumilast

Teilnahmeberechtigung

Kriterien:

Main Inclusion Criteria:

- Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)

- Currently stable COPD with no change in COPD treatment in the prior 4 weeks

Main Exclusion Criteria:

- Clinical diagnosis of asthma

- Poorly controlled COPD

- Regular need for daily oxygen therapy

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
AstraZeneca AstraZeneca Study Director AstraZeneca
Ort
Einrichtung:
ALTANA Pharma | Cities in Alabama, Alabama, United States
ALTANA Pharma | Cities in Arizona, Arizona, United States
ALTANA Pharma | Cities in California, California, United States
ATLANA Pharma | Cities in Colorado, Colorado, United States
ALTANA Pharma | Cities in Conneticut, Connecticut, United States
ALTANA Pharma | Cities in Delaware, Delaware, United States
ALTANA Pharma | Cities in Florida, Florida, United States
ALTANA Pharma | Cities in Georgia, Georgia, United States
ALTANA Pharma | Cities in Idaho, Idaho, United States
ALTANA Pharma | Cities in Indiana, Indiana, United States
ALTANA Pharma | Cities in Iowa, Iowa, United States
ALTANA Pharma | Cities in Kansas, Kansas, United States
ALTANA Pharma | Cities in Kentucky, Kentucky, United States
ALTANA Pharma | Cities in Louisiana, Louisiana, United States
ALTANA Pharma | Cities in Maryland, Maryland, United States
ALTANA Pharma | Cities in Michigan, Michigan, United States
ALTANA Pharma | Cities in Missouri, Missouri, United States
ALTANA Pharma | Cities in Nebraska, Nebraska, United States
ALTANA Pharma | Cities in Nevada, Nevada, United States
ALTANA Pharma | Cities in New Jersey, New Jersey, United States
ALTANA Pharma | Cities in New York, New York, United States
ALTANA Pharma | Cities in North Carolina, North Carolina, United States
ALTANA Pharma | Cities in Ohio, Ohio, United States
ALTANA Pharma | Cities in Oregon, Oregon, United States
ALTANA Pharma | Cities in Pennsylvania, Pennsylvania, United States
ALTANA Pharma | Cities in Rhode Island, Rhode Island, United States
ALTANA Pharma | Cities in South Carolina, South Carolina, United States
ALTANA Pharma | Cities in Texas, Texas, United States
ALTANA Pharma | Cities in Utah, Utah, United States
ALTANA Pharma | Cities in Virginia, Virginia, United States
ALTANA Pharma | Cities in Washington, Washington, United States
ALTANA Pharma | Cities in West Virginia, West Virginia, United States
ALTANA Pharma | Cities in Argentina, Argentina
ALTANA Pharma | Cities in Canada, Canada
ALTANA Pharma | Cities in Colombia, Colombia
ALTANA Pharma | Cities in Mexico, Mexico
ALTANA Pharma | Cities in Peru, Peru
Standort Länder

Argentina

Canada

Colombia

Mexico

Peru

United States

Überprüfungsdatum

September 2016

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double

Quelle: ClinicalTrials.gov