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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Formoterol Turbuhaler; Drug: Budesonide/formoterol (SYMBICORT) pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419744

D589CC00003

Details and patient eligibility

About

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.

Enrollment: 1,200 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind