Efficacy Study of the Effect of Budesonide on Emphysema

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00232674
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study Start: 1999-07
• Study Completion: 2004-02
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-05
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇩🇰 Gentofte, Denmark