Efficacy Study of the Effect of Budesonide on Emphysema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232674
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : January 24, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Pulmicort (budesonide) Turbuhaler Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Inhaled Corticosteroids on the Development of Emphysema in Smokers Assessed by Computed Tomography (CT).
Study Start Date : July 1999
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide
U.S. FDA Resources

Primary Outcome Measures :
  1. The primary variable in the study was change in lung density measured by Computed Tomography annually.

Secondary Outcome Measures :
  1. Decline in lung Function (FEV1) and exacerbation rate were measured biannually and decline in diffusion capacity (TLCO) annually.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232674

Research Site
Gentofte, Denmark
Sponsors and Collaborators
Study Director: Astra Zeneca AstraZeneca Identifier: NCT00232674     History of Changes
Other Study ID Numbers: AD-004-0001
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pathologic Processes
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists