A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00419744

Purpose

The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Formoterol Turbuhaler	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: 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, Safety/Efficacy Study
Official Title:	A Phase IIIB, 12-Month, Double-Blind, Double-Dummy,Randomised, Parallel-Group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-Daily and 80/4.5 μg x 2 Actuations Twice-Daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-Daily in COPD Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of this study is to compare efficacy for preventing exacerbations of SYMBICORT pMDI 160/4.5 μg x 2 actuations bid and 80/4.5 μg x 2 actuations bid compared to formoterol Turbuhaler® 4.5 μg x 2 inhalations bid in COPD subjects.

Secondary Outcome Measures:

The secondary objective of this study is to demonstrate the safety of both SYMBICORT® pMDI doses compared to that of formoterol Turbuhaler® in subjects with COPD.

Estimated Enrollment:	1200
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A current clinical diagnosis of COPD with COPD symptoms for more than 2 years
Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit

Exclusion Criteria:

A history of asthma at or after 18 years of age
A history of allergic rhinitis at or after 18 years of age
Subjects taking oral steroids
Any significant disease or disorder that may jeopardize a subject's safety

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419744

Show 149 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Christer Hultquist, MD

AstraZeneca

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	D589CC00003
Study First Received:	January 5, 2007
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00419744
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive
Symbicort
Respiratory Tract Diseases
Lung Diseases

Budesonide
Formoterol
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009