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
Phase 3
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT00206154
- Lead Sponsor
- AstraZeneca
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
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 6 months treatment period
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇿🇦Umkomaas, South Africa