The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD

This study has been terminated.

Sponsor:

Information provided by:

Inonu University

ClinicalTrials.gov Identifier:

NCT00274222

First received: January 9, 2006

Last updated: NA

Last verified: January 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

January 9, 2006

Last Updated Date

January 9, 2006

Start Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD

Official Title ^ICMJE

Not Provided

Brief Summary

This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD).

Detailed Description

Patients, hospitalized with AECOPD, were randomized into three groups. Group I received only bronchodilator treatment (BDT), Group II received SC (40 mg prednisolon) plus BDT, and Group III received nebulized budesonide (NB)(1500 mcg qid) plus BDT. Improvement rates in multiple parameters during 10-day hospitalization, and acute exacerbation and re-hospitalization rates within one-month after discharge were compared between the groups.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

COPD Acute Exacerbation

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

120

Completion Date

October 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study

Exclusion Criteria:

COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00274222

Other Study ID Numbers ^ICMJE

2006-3

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Inonu University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

HAKAN GUNEN, MD

INONU UNIVERSITY PULMONARY MEDICINE

Information Provided By

Inonu University

Verification Date

January 2006

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

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