Efficacy Study of the Effect of Budesonide on Emphysema

This study has been completed.

First Received on October 4, 2005. Last Updated on January 21, 2011 History of Changes

Sponsor:	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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	The Effect of Inhaled Corticosteroids on the Development of Emphysema in Smokers Assessed by Computed Tomography (CT).

Resource links provided by NLM:

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

Drug Information available for: Budesonide

U.S. FDA Resources

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:	July 1999
Study Completion Date:	February 2004

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00232674 History of Changes
Other Study ID Numbers:	AD-004-0001
Study First Received:	October 4, 2005
Last Updated:	January 21, 2011
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:

Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:

Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012