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

Phase 3CompletedNCT00206167

AstraZeneca1,600 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,600

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Budesonide/formoterol pMDIDRUG

Formoterol TurbuhalerDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (216)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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Research Site

Birmingham, Alabama, United States

Research Site

Huntsville, Alabama, United States

Research Site

Jasper, Alabama, United States

Research Site

Muscle Shoals, Alabama, United States

Research Site

Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

Research Site

Fort Smith, Arkansas, United States

Research Site

Carmichael, California, United States

Research Site

La Jolla, California, United States

...and 206 more locations