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

Sponsor
Inonu University (Other)
Overall Status
Terminated
CT.gov ID
NCT00274222
Collaborator
(none)
120
Enrollment
33
Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Study Start Date :
    Jan 1, 2003
    Study Completion Date :
    Oct 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Inonu University

      Investigators

      • Study Chair: HAKAN GUNEN, MD, INONU UNIVERSITY PULMONARY MEDICINE

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00274222
      Other Study ID Numbers:
      • 2006-3
      First Posted:
      Jan 10, 2006
      Last Update Posted:
      Jan 10, 2006
      Last Verified:
      Jan 1, 2006
      Keywords provided by , ,
      COPD, nebulized budesonide, systemic corticosteroids

      Study Results

      No Results Posted as of Jan 10, 2006