Efficacy Study of the Effect of Budesonide on Emphysema
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Pulmicort (budesonide) Turbuhaler (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Astra Zeneca, Study Director, Affiliation: AstraZeneca
Summary
To assess the effect of up to 4 years treatment with budesonide on progression of emphysema
in patients with Chronic Obstructive Lung Disease.
Clinical Details
Official title: The Effect of Inhaled Corticosteroids on the Development of Emphysema in Smokers Assessed by Computed Tomography (CT).
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary variable in the study was change in lung density measured by Computed Tomography annually.
Secondary outcome: Decline in lung Function (FEV1) and exacerbation rate were measured biannually and decline in diffusion capacity (TLCO) annually.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Research Site, Gentofte, Denmark
Additional Information
Starting date: January 1999
Ending date: April 2005
Last updated: January 11, 2008
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