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NCT00232674 Clinical Trial

Efficacy Study of the Effect of Budesonide on Emphysema

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
The Effect of Inhaled Corticosteroids on the Development of Emphysema in Smokers Assessed by Computed Tomography (CT).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00232674
Other study ID # AD-004-0001
Secondary ID
Status Completed
Phase Phase 4
First received October 4, 2005
Last updated January 21, 2011
Start date July 1999
Est. completion date February 2004

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date February 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pulmicort (budesonide) Turbuhaler

Locations
Country Name City State
Denmark Research Site Gentofte

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary variable in the study was change in lung density measured by Computed Tomography annually.
Secondary Decline in lung Function (FEV1) and exacerbation rate were measured biannually and decline in diffusion capacity (TLCO) annually.
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