Comparison Between Symbicort® and Prednisolone in COPD (SPACE)

January 21, 2011 updated by: AstraZeneca

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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