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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Budesonide pMDI; Drug: Formoterol Turbuhaler; Drug: Budesonide/formoterol pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00206154

D5899C00002

EurodraCT No: 2004-001183-41

Details and patient eligibility

About

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)

Enrollment: 1,500 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind