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).
Verified date | January 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
To assess the effect of up to 4 years treatment with budesonide on progression of emphysema in patients with Chronic Obstructive Lung Disease.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Research Site | Gentofte |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Denmark,
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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