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Comparison Between Symbicort® and Prednisolone in COPD (SPACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259779
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : January 24, 2011
Information provided by:

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 Obstructive Pulmonary Disease (COPD).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: budesonide/formoterol Drug: Prednisolone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : September 2005
Actual Study Completion Date : July 2007

Intervention Details:
  • Drug: budesonide/formoterol
    Other Name: Symbicort
  • Drug: Prednisolone

Primary Outcome Measures :
  1. Forced Expiratory Volume in one second (FEV1)

Secondary Outcome Measures :
  1. Number of patients with treatment failures
  2. Time to first exacerbation
  3. Number of patients developing an exacerbation
  4. Diary cards
  5. Quality of Life
  6. - Adverse Events (AEs)
  7. Serious Adverse Events (SAEs) and Discontinuations due to AEs
  8. Variables will be assessed before and over the 2+12 weeks treatment period

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259779

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Research Site
Aalbaek, Denmark
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Aalborg, Denmark
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Christiansfeld, Denmark
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Erfurt, Denmark
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Norager, Denmark
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Oksbol, Denmark
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Saeby, Denmark
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Lohja, Finland
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Pietarsaari, Finland
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Porvoo, Finland
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Tammisaari, Finland
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Berlin, Germany
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Leipzig, Germany
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Marburg, Germany
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Fredrikstad, Norway
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Harstad, Norway
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Molde, Norway
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Oslo, Norway
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Straume, Norway
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Akersberga, Sweden
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Alingsas, Sweden
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Atvidaberg, Sweden
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Borlange, Sweden
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Goteborg, Sweden
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Hollviken, Sweden
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Kilafors, Sweden
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Limhamn, Sweden
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Lindesberg, Sweden
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Lulea, Sweden
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Malmo, Sweden
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Motala, Sweden
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Sigtuna, Sweden
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Stockholm, Sweden
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Trosa, Sweden
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Tumba, Sweden
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Uppsala, Sweden
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Örebro, Sweden
Sponsors and Collaborators
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Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00259779    
Other Study ID Numbers: D5892L00002
Eudra CT 2005-001090-10
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol Fumarate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action