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

Phase 3CompletedNCT00206154

AstraZeneca1,500 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,500

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Budesonide/formoterol pMDIDRUG

Budesonide 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 (212)

Outcomes

Primary Outcomes

Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Secondary Outcomes

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

Data from ClinicalTrials.gov

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Research Site

Birmingham, Alabama, United States

Research Site

Jasper, Alabama, United States

Research Site

Mobile, Alabama, United States

Research Site

Glendale, Arizona, United States

Research Site

Mesa, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Fort Smith, Arkansas, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Searcy, Arkansas, United States

Research Site

Anaheim, California, United States

...and 202 more locations