Comparison Between Symbicort® and Prednisolone in COPD - Full Text View

Purpose

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	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: budesonide/formoterol Drug: Prednisolone	Phase III

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

ChemIDplus related topics:

Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Budesonide Symbicort

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Forced Expiratory Volume in one second (FEV1)

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	September 2005
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259779

Locations


Denmark
	Research Site
	Aalborg, Denmark
	Research Site
	Aalbaek, Denmark
	Research Site
	Christiansfeld, Denmark
	Research Site
	Norager, Denmark
	Research Site
	Oksbol, Denmark
	Research Site
	Saeby, Denmark
	Research Site
	Erfurt, 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
	STRAUME, Norway
	Research Site
	MOLDE, Norway
	Research Site
	OSLO, Norway
	Research Site
	FREDRIKSTAD, Norway
	Research Site
	HARSTAD, Norway

Sweden
	Research Site
	Trosa, Sweden
	Research Site
	Alingsas, Sweden
	Research Site
	Örebro, Sweden
	Research Site
	Motala, Sweden
	Research Site
	Limhamn, Sweden
	Research Site
	Goteborg, Sweden
	Research Site
	Atvidaberg, Sweden
	Research Site
	Akersberga, Sweden
	Research Site
	Sigtuna, Sweden
	Research Site
	Hollviken, Sweden
	Research Site
	Tumba, Sweden
	Research Site
	Kilafors, Sweden
	Research Site
	Stockholm, Sweden
	Research Site
	Borlange, Sweden
	Research Site
	Malmo, Sweden
	Research Site
	Uppsala, Sweden
	Research Site
	Lindesberg, Sweden
	Research Site
	Lulea, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Symbicort Medical Science Director, MD	AstraZeneca

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D5892L00002, Eudra CT 2005-001090-10, SPACE
First Received:	November 29, 2005
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00259779
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive

Symbicort

Respiratory Tract Diseases

Methylprednisolone

Lung Diseases

Prednisolone

Budesonide

Formoterol

Methylprednisolone acetate

Prednisolone acetate

Methylprednisolone Hemisuccinate

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic beta-Agonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Physiological Effects of Drugs

Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Antiemetics

Protective Agents

Neuroprotective Agents

Glucocorticoids

Hormones

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00259779