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

Not Recruiting

Trial ID: 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).

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

Stanford Investigator(s)

Eligibility


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

Intervention(s):

drug: Budesonide/formoterol pMDI

drug: Formoterol Turbuhaler

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ware Kuschner
6504935000 x 63544