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

Completed · Phase 3

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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)

Key facts

Study ID

NCT00206154

Run by

AstraZeneca

People needed

1500

Starts

2005-04-01

Expected to finish

2006-12-01

Last updated by the study team

2009-03-27

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• 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
• Research Site — Fullerton, California, United States
• Research Site — Irvine, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Orange, California, United States
• Research Site — Rancho Cordova, California, United States
• Research Site — Riverside, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Jose, California, United States
• Research Site — Sepulveda, California, United States
• Research Site — Signal Hill, California, United States
• Research Site — Stockton, California, United States
• Research Site — Torrance, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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