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Efficacy Study of the Effect of Budesonide on Emphysema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00232674
First Posted: October 5, 2005
Last Update Posted: January 24, 2011
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.
Information provided by:
AstraZeneca
  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 4

Study Type: Interventional
Study Design: 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).

Resource links provided by NLM:


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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00232674


Locations
Denmark
Research Site
Gentofte, Denmark
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Astra Zeneca AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00232674     History of Changes
Other Study ID Numbers: AD-004-0001
First Submitted: October 4, 2005
First Posted: October 5, 2005
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
Emphysema
Respiratory Tract Diseases
Pathologic Processes
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists