Adherence study in COPD patients

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 be away from home for a significant part of the study without
• access to cellular connectivity are excluded because of the challenges of collecting
• data and providing information to these patients who are unable to use the service.
• • Patients with thoracic surgery within 6 months of Visit 1.
• • Patients who have received a lung transplant or are currently active on the lung
• transplant waiting list.