Comparison Between Symbicort® and Prednisolone in COPD (SPACE)

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: budesonide/formoterol; Drug: Prednisolone

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aalbaek, Denmark
    • Research Site
  • Aalborg, Denmark
    • Research Site
  • Christiansfeld, Denmark
    • Research Site
  • Erfurt, Denmark
    • Research Site
  • Norager, Denmark
    • Research Site
  • Oksbol, Denmark
    • Research Site
  • Saeby, Denmark
    • Research Site
• Finland
  • Lohja, Finland
    • Research Site
  • Pietarsaari, Finland
    • Research Site
  • Porvoo, Finland
    • Research Site
  • Tammisaari, Finland
    • Research Site
• Germany
  • Berlin, Germany
    • Research Site
  • Leipzig, Germany
    • Research Site
  • Marburg, Germany
    • Research Site
• Norway
  • Fredrikstad, Norway
    • Research Site
  • Harstad, Norway
    • Research Site
  • Molde, Norway
    • Research Site
  • Oslo, Norway
    • Research Site
  • Straume, Norway
    • Research Site
• Sweden
  • Akersberga, Sweden
    • Research Site
  • Alingsas, Sweden
    • Research Site
  • Atvidaberg, Sweden
    • Research Site
  • Borlange, Sweden
    • Research Site
  • Goteborg, Sweden
    • Research Site
  • Hollviken, Sweden
    • Research Site
  • Kilafors, Sweden
    • Research Site
  • Limhamn, Sweden
    • Research Site
  • Lindesberg, Sweden
    • Research Site
  • Lulea, Sweden
    • Research Site
  • Malmo, Sweden
    • Research Site
  • Motala, Sweden
    • Research Site
  • Sigtuna, Sweden
    • Research Site
  • Stockholm, Sweden
    • Research Site
  • Trosa, Sweden
    • Research Site
  • Tumba, Sweden
    • Research Site
  • Uppsala, Sweden
    • Research Site
  • Örebro, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Forced Expiratory Volume in one second (FEV1)

Secondary Outcome Measures

Outcome Measure
Quality of Life
Number of patients with treatment failures
Time to first exacerbation
Number of patients developing an exacerbation
Diary cards
- 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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Stallberg B, Selroos O, Vogelmeier C, Andersson E, Ekstrom T, Larsson K. Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD. A double-blind, randomised, non-inferiority, parallel-group, multicentre study. Respir Res. 2009 Feb 19;10(1):11. doi: 10.1186/1465-9921-10-11.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion: December 7, 2022
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: November 29, 2005
• First Submitted That Met QC Criteria: November 29, 2005
• First Posted (Estimate): December 1, 2005

Study Record Updates

• Last Update Posted (Estimate): January 24, 2011
• Last Update Submitted That Met QC Criteria: January 21, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Prednisolone; Budesonide; Formoterol Fumarate
• Other Study ID Numbers: D5892L00002; Eudra CT 2005-001090-10; SPACE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No