Adherence Study in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Arm 1: BreatheMate device with application; Arm 2: BreatheMate device without application
Intervention description: The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. Subjects will receive audio-visual daily reminders (beeps and flashes) on the BreatheMate Bluetooth device. The bluetooth device transmits this data to a cellular phone that is provided to all subjects in the study. Subjects in the intervention group will also receive audio-visual alerts (beeps, flashes) from the bluetooth device to take their medication.; The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. The functionality of audio-visual daily reminders (beeps and flashes) is deactivated for this control group.
The BreatheMate service also includes a cellular phone that will display whether the Bluetooth monitoring device is paired and communicating with the cellular phone. The Bluetooth device will transmit data regarding medication usage to the cellular phone.
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 40 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; Respiratory; adherence; medication reminders

Summary:

      A randomized clinical study to assess the impact of Symbicort® pMDI medication reminders on
      adherence in COPD patients
    

Eligibility criteria:

        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) <0.70 at some point in the past 3 years.

          -  Moderate to Very Severe COPD as defined by a post-bronchodilator FEV1 <80% of
             predicted on most recent spirometry.

          -  Had been on an ICS/LABA combination therapy of a brand and dose approved forCOPD, for
             at least 3 months prior to screening.

          -  Current or previous smoker with a smoking history equivalent to 10 or more pack years
             (1 pack year = 20 cigarettes smoked per day for 1 year).

          -  Willing to discontinue all medications containing both a LABA and an ICS and to begin
             Symbicort 160/4.5 μg, 2 inhalations bid.

          -  Must be willing to make a return visit, and complete all study assessments for the
             duration of study.

          -  Life expectancy >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 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.