A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

Criteria

Inclusion Criteria:

• A current clinical diagnosis of COPD with COPD symptoms for more than 2 years

• Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)

• A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit

Exclusion Criteria:

• A history of asthma at or after 18 years of age

• A history of allergic rhinitis at or after 18 years of age

• Subjects taking oral steroids

• Any significant disease or disorder that may jeopardize a subject's safety