Efficacy Study of the Effect of Budesonide on Emphysema

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00232674

Enrollment

240

Registered

2005-10-05

Start date

1999-07-31

Completion date

2004-02-29

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease

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.

Interventions

DRUGPulmicort (budesonide) Turbuhaler

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026