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 - Full Text View

Sponsored by:	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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

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

U.S. FDA Resources

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

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

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

Study ID Numbers:	D5899C00001, EurodraCT No: 2004-001 168-28, SUN
Study First Received:	September 13, 2005
Last Updated:	November 27, 2007
ClinicalTrials.gov Identifier:	NCT00206167
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Lung Diseases, Obstructive
Symbicort
Respiratory Tract Diseases
Guaifenesin

Phenylephrine
Lung Diseases
Budesonide
Formoterol
Phenylpropanolamine
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