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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00206167
• Lead Sponsor: AstraZeneca

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2007-09
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-26
• Last Update Posted: 2009-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period

Secondary Outcome Measures

Name	Time	Method
Health care utilization
Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
all variables assessed over the 12 months treatment period

Trial Locations

Locations (1)

Research Site; 🇷🇴 Iasi, Romania