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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
  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:

MedlinePlus related topics: Steroids
Drug Information available for: Budesonide
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274222

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

No publications provided

ClinicalTrials.gov Identifier: NCT00274222     History of Changes
Other Study ID Numbers: 2006-3
Study First Received: January 9, 2006
Last Updated: January 9, 2006
Health Authority: TURKEY: INONU UNIVERSITY PULMONARY MEDICINE

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

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013