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OpenTrials
Completed

NCT Number: NCT00259779

Comparison Between Symbicort® and Prednisolone in COPD

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide/formoterol

Drug

Other names: Symbicort

Prednisolone

Drug

Primary outcomes

  1. Forced Expiratory Volume in one second (FEV1)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: SPACE

Important dates

Study start
2005
Study completion
2007
First posted
Dec 1, 2005
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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