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

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

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)

Drug Information available for: 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
Study 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 January 14, 2009