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

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Budesonide/formoterol pMDI (Drug); Budesonide pMDI (Drug); Formoterol Turbuhaler (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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)

Official title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Secondary outcome:

Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries

Health care utilization

Pharmacokinetics (subgroup)

Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.

- all variables assessed over the 6 months treatment period

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

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Last updated: January 11, 2008