Adherence Study in COPD Patients

Inclusion Criteria

For inclusion in the study subjects should fulfil the following criteria:

• Signed informed consent at Visit 1 prior to any study specific procedures
• Outpatient adults 40 years and older
• A diagnosis of COPD confirmed by a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) 12 months.
• Must be willing to comply with all study procedures including being able to remove and attach device to the inhaler.
• Must be able and willing to read and write/respond using the electronic device provided.

Exclusion Criteria

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• Previous randomization in the present study.
• Patients who have been randomized in a clinical study and received an investigational product within 30 days of Visit 1 (participation is defined as the completion of a treatment related visit).
• Current diagnosis of asthma.
• Known history of drug or alcohol abuse which, in the opinion of the Investigator, may interfere with subject's ability to participate or comply with the study.
• An acute exacerbation of COPD that required hospitalization or emergency room visit or treatment with systemic steroids and/or antibiotics during the 28 days before Visit 1. Patients who had a COPD exacerbation within 28 days of Visit 1 can be re-screened once. Re-screening can occur no earlier than 28 days from the last dose of systemic steroids and/or antibiotics and/or hospitalization, whichever is later.
• Enrolled patients that have a COPD exacerbation during the run-in period, defined as worsening symptoms which in the judgment of the Investigator requires treatment with systemic steroids and/or antibiotics and/or hospitalization. Patients who had a COPD exacerbation during the run-in period can be re-screened once. Re-screening can occur no earlier than 28 days from the last dose of systemic steroid and/or antibiotics and/or hospitalization, whichever is later.
• Any hospital admissions due to ischemic heart disease or heart failure within 3 months of study enrollment.
• Any significant disease or disorder (e.g., gastrointestinal, liver, renal, neurologic, musculoskeletal, endocrine, metabolic, infectious, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study.
• History of lung or upper airway cancer and any other malignancy not in remission for 5 years or more, except for patients who have had basal cell carcinoma, or in situ carcinoma of the cervix provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
• Use or planned use of systemic corticosteroids as a maintenance treatment (defined as daily or every other day treatment for 21 or more days) for inflammatory or immunologic conditions unrelated to their COPD.
• Planned hospitalization or surgical procedure requiring inpatient stay during the study.
• Pregnancy, breast-feeding or planned pregnancy during the study; fertile women not using acceptable contraceptive measures, as judged by the Investigator. Female subjects who are not post-menopausal or surgically sterile must have a negative urine pregnancy test (urine dipstick test only) prior to randomization and must comply with contraceptive methods.
• Any clinically relevant abnormal findings in physical examination or vital signs, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study.
• Known or suspected hypersensitivity to the study therapy (Symbicort).
• Patients who are unable or unwilling to use mobile communication devices, or patients who plan to