Status:

COMPLETED

Comparison Between Symbicort® and Prednisolone in COPD

Lead Sponsor:

AstraZeneca

Conditions:

Chronic Obstructive Pulmonary Disease

Eligibility:

All Genders

40+ years

Phase:

PHASE3

Brief Summary

To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic ...

Eligibility Criteria

Inclusion

  • Patients with chronic obstructive pulmonary disease and an acute exacerbation
  • After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value.
  • Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease

Exclusion

  • Diagnosis/history of asthma
  • Oxygen uptake (saturation) is \<92% after the initial acute treatment
  • A requirement for regular use of oxygen therapy
  • Regular treatment with any inhaled steroid \>1 000 µg/day at study entry
  • Additional inclusion and exclusion criteria will be evaluated by the investigator

Key Trial Info

Start Date :

September 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2007

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00259779

Start Date

September 1 2005

End Date

July 1 2007

Last Update

January 24 2011

Active Locations (37)

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Page 1 of 10 (37 locations)

1

Research Site

Aalborg, Denmark

2

Research Site

Ålbæk, Denmark

3

Research Site

Christiansfeld, Denmark

4

Research Site

Erfurt, Denmark