ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00259779
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT00259779


Locations
Denmark
Research Site
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
Finland
Research Site
Lohja, Finland
Research Site
Pietarsaari, Finland
Research Site
Porvoo, Finland
Research Site
Tammisaari, Finland
Germany
Research Site
Berlin, Germany
Research Site
Leipzig, Germany
Research Site
Marburg, Germany
Norway
Research Site
Fredrikstad, Norway
Research Site
Harstad, Norway
Research Site
Molde, Norway
Research Site
Oslo, Norway
Research Site
Straume, Norway
Sweden
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00259779     History of Changes
Other Study ID Numbers: D5892L00002
Eudra CT 2005-001090-10
SPACE
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Methylprednisolone
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists