Chronic Obstructive Pulmonary Disease
Conditions
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)
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czechia, Netherlands, Poland, South Africa, United States
Outcome results
None listed