Back to resultsEfficacy Study of the Effect of Budesonide on Emphysema
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Pulmicort (budesonide) Turbuhaler
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease
Eligibility 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
Sites / Locations
- Research Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232674
Brief Title
Efficacy Study of the Effect of Budesonide on Emphysema
Official Title
The Effect of Inhaled Corticosteroids on the Development of Emphysema in Smokers Assessed by Computed Tomography (CT).
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pulmicort (budesonide) Turbuhaler
Primary Outcome Measure Information:
Title
The primary variable in the study was change in lung density measured by Computed Tomography annually.
Secondary Outcome Measure Information:
Title
Decline in lung Function (FEV1) and exacerbation rate were measured biannually and decline in diffusion capacity (TLCO) annually.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astra Zeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Gentofte
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of the Effect of Budesonide on Emphysema
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