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
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