Overview

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

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Formoterol Fumarate
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