Efficacy Study of the Effect of Budesonide on Emphysema - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00232674

Purpose

To assess the effect of up to 4 years treatment with budesonide on progression of emphysema in patients with Chronic Obstructive Lung Disease.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Pulmicort (budesonide) Turbuhaler	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) CT Scans Emphysema

Drug Information available for: Corticosteroids Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Inhaled Corticosteroids on the Development of Emphysema in Smokers Assessed by Computed Tomography (CT).

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary variable in the study was change in lung density measured by Computed Tomography annually.

Secondary Outcome Measures:

Decline in lung Function (FEV1) and exacerbation rate were measured biannually and decline in diffusion capacity (TLCO) annually.

Estimated Enrollment:	240
Study Start Date:	January 1999
Study Completion Date:	April 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical Chronic Obstructive Pulmonary Disease diagnosis
smoker

Exclusion Criteria:

No exacerbation within the last 30 days
no long term use of oral corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232674

Locations

Denmark
Research Site
Gentofte, Denmark

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Astra Zeneca

AstraZeneca

More Information

Study ID Numbers:	AD-004-0001
Study First Received:	October 4, 2005
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00232674
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:

Chronic Obstructive Pulmonary Disease

Study placed in the following topic categories:

Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Budesonide
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Glucocorticoids
Hormones

Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009