Efficacy Study of the Effect of Budesonide on Emphysema - Tabular View

Tracking Information

First Received Date ^ICMJE

October 4, 2005

Last Updated Date

March 18, 2009

Start Date ^ICMJE

January 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary variable in the study was change in lung density measured by Computed Tomography annually.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00232674 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Decline in lung Function (FEV1) and exacerbation rate were measured biannually and decline in diffusion capacity (TLCO) annually.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy Study of the Effect of Budesonide on Emphysema

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Drug: Pulmicort (budesonide) Turbuhaler

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

240

Completion Date

February 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00232674

Responsible Party

Study ID Numbers ^ICMJE

AD-004-0001

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Astra Zeneca

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP