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

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:	NCT00206154

Purpose

The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with 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: Budesonide 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 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients

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 6 months treatment period

Secondary Outcome Measures:

Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Health care utilization
Pharmacokinetics (subgroup)
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
- all variables assessed over the 6 months treatment period

Estimated Enrollment:	1500
Study Start Date:	April 2005
Study Completion Date:	December 2006

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: NCT00206154

Show 215 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00206154 History of Changes
Other Study ID Numbers:	D5899C00002, EurodraCT No: 2004-001183-41
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 12, 2012