Official Title: “A Randomised, Double Blind, Double Dummy, Multicentre Phase III Study Comparing the Efficacy of Budesonide/Formoterol (Symbicort® Forte Turbuhaler®) and Oral Prednisolone + Formoterol (Oxis® Turbuhaler) During Two Weeks, in COPD Patients With an Acute Exacerbation, Followed by Twelve Weeks Open Follow up Period With Budesonide/Formoterol (Symbicort Forte Turbuhaler)”

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 Obstructive Pulmonary Disease (COPD).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Drug: budesonide/formoterol
• Drug: Prednisolone

Primary Measures

• Forced Expiratory Volume in one second (FEV1)

Secondary Measures

• Number of patients with treatment failures
• Time to first exacerbation
• Number of patients developing an exacerbation
• Diary cards
• Quality of Life
• - Adverse Events (AEs)
• Serious Adverse Events (SAEs) and Discontinuations due to AEs
• Variables will be assessed before and over the 2+12 weeks treatment period

Inclusion Criteria:

• 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 Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Symbicort Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259779

Study ID Number: D5892L00002

ClinicalTrials.gov Identifier: NCT00259779

Health Authority: Sweden: Medical Products Agency

AstraZeneca Clinical Trial Information - Outside US