Efficacy Study of the Effect of Budesonide on Emphysema
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00232674
Collaborator
(none)
240
1
55.1
4.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
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).
Study Start Date
:
Jul 1, 1999
Actual Study Completion Date
:
Feb 1, 2004
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Gentofte | Denmark |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Astra Zeneca, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00232674
Other Study ID Numbers:
- AD-004-0001
First Posted:
Oct 5, 2005
Last Update Posted:
Jan 24, 2011
Last Verified:
Jan 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms: