A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

This study has been completed.

First Received on September 13, 2005. Last Updated on March 26, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206167

Purpose

The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Phenylpropanolamine Formoterol fumarate Budesonide Arformoterol Formoterol Triaminic Guaifenesin Symbicort Arformoterol Tartrate Phenylpropanolamine hydrochloride Naphazoline hydrochloride Naphazoline

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period

Secondary Outcome Measures:

Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Health care utilization
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
all variables assessed over the 12 months treatment period

Estimated Enrollment:	1600
Study Start Date:	April 2005
Study Completion Date:	September 2007

Eligibility

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

Criteria

Inclusion Criteria:

A clinical diagnosis of COPD with symptoms for more than 2 years.
Smoking history of 10 or more pack years
A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion Criteria:

A history of asthma
Patients taking oral steroids
Any significant disease or disorder that may jeopardize the safety of the patient

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206167

Show 216 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00206167 History of Changes
Other Study ID Numbers:	D5899C00001, EurodraCT No: 2004-001 168-28, SUN
Study First Received:	September 13, 2005
Last Updated:	March 26, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012