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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00274222
First Posted: January 10, 2006
Last Update Posted: January 10, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Inonu University
  Purpose
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).

Condition
COPD Acute Exacerbation

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by Inonu University:

Estimated Enrollment: 120
Study Start Date: January 2003
Estimated Study Completion Date: October 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274222


Sponsors and Collaborators
Inonu University
Investigators
Study Chair: HAKAN GUNEN, MD INONU UNIVERSITY PULMONARY MEDICINE
  More Information

ClinicalTrials.gov Identifier: NCT00274222     History of Changes
Other Study ID Numbers: 2006-3
First Submitted: January 9, 2006
First Posted: January 10, 2006
Last Update Posted: January 10, 2006
Last Verified: January 2006

Keywords provided by Inonu University:
COPD, nebulized budesonide, systemic corticosteroids

Additional relevant MeSH terms:
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists