Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece

The CAT is a patient-completed questionnaire assessing globally the impact of COPD on health status. It contains 8 items, where each item has a score range from 0 to 5. The CAT score is calculated by summing up the scores from the 8 items. CAT score ranges from 0 to 40. Higher score denotes a more severe impact of COPD on a patient's life. CAT score \<10 corresponding to mild impact on patients life is usually considered representing patients without impaired health status.

Time frame: At baseline and at 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values are included.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. EQ-VAS score ranges from 0 to 100 where 0 represents the worst state the patient can imagine and 100 the best. Higher scores indicated better health state.

Time frame: At baseline and at 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values are included.

mMRC is a five-level rating scale ranging from 0 to 4 based on the patient's perception of dyspnea in daily activities. A higher score indicates a higher grade of breathlessness.

Time frame: At baseline and at 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values are included.

Days of missed medication for COPD is reported.

Time frame: up to 3 months

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values and non-missing endpoint values are included.

Number of patients adherence to medication of COPD patients according to the Simplified Medication Adherence Questionnaire (SMAQ) three-months after the switch is reported.

Time frame: At 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values and non-missing endpoint values are included.

Number of patients per medication frequency category according to Simplified Medication Adherence Questionnaire (SMAQ) is reported.

Time frame: At 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values and non-missing endpoint values are included.

Overall satisfaction according to Question 14 of PASAPQ (Part 1). Question 14 of PASAPQ has a score range from 1= very dissatisfied to 7 = very satisfied.

Time frame: At 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values are included.

Percentage of patients by preference for inhaler according to Part 2 of the PASAPQ is reported.

Time frame: At 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values are included.

Adherence is measured with the Simplified Medication Adherence Questionnaire (SMAQ), which is a short questionnaire including 6 questions, that assess patient adherence to the medication.

Time frame: At 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values are included.

The CAT is a patient-completed questionnaire assessing globally the impact of COPD on health status. It contains 8 items, where each item has a score range from 0 to 5. The CAT score is calculated by summing up the scores from the 8 items. CAT score ranges from 0 to 40. Higher score denotes a more severe impact of COPD on a patient's life. CAT score \<10 corresponding to mild impact on patient's life is usually considered representing patients without impaired health status. CAT≥10 refers to impaired health status. The percentages of patients with CAT CAT≥10 at baseline and at Month 3 were reported below.

Time frame: At baseline and at 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. The reporting groups below are not mutually exclusive.

EQ-5D-5L descriptive system comprises of 5 dimensions-mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: not at all (level 1), mild (level 2), moderate (level 3), severe (level 4), extreme/leading to incapacity (level 5), with highest level corresponding to worst outcome. Subjects had to indicate their health state by choosing the appropriate level from each dimension. The dimension for anxiety/depression is reported in this endpoint.

Time frame: At baseline and at 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®.

EQ-5D-5L descriptive system comprises of 5 dimensions-mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: not at all (level 1), mild (level 2), moderate (level 3), severe (level 4), extreme/leading to incapacity (level 5), with highest level corresponding to worst outcome. Subjects had to indicate their health state by choosing the appropriate level from each dimension. The dimension for self-care is reported in this endpoint.

Time frame: At baseline and at 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®.

EQ-5D-5L descriptive system comprises of 5 dimensions-mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: not at all (level 1), mild (level 2), moderate (level 3), severe (level 4), extreme/leading to incapacity (level 5), with highest level corresponding to worst outcome. Subjects had to indicate their health state by choosing the appropriate level from each dimension. The dimension for pain/discomfort is reported in this endpoint.

Time frame: At baseline and at 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®.

EQ-5D-5L descriptive system comprises of 5 dimensions-mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: not at all (level 1), mild (level 2), moderate (level 3), severe (level 4), extreme/leading to incapacity (level 5), with highest level corresponding to worst outcome. Subjects had to indicate their health state by choosing the appropriate level from each dimension. The dimension for usual activities is reported in this endpoint.

Time frame: At baseline and at 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®.

EQ-5D-5L descriptive system comprises of 5 dimensions-mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: not at all (level 1), mild (level 2), moderate (level 3), severe (level 4), extreme/leading to incapacity (level 5), with highest level corresponding to worst outcome. Subjects had to indicate their health state by choosing the appropriate level from each dimension. The dimension for mobility is reported in this endpoint.

Time frame: At baseline and at 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®.

Calculated from questions 1 to 13 in Part 1 of the PASAPQ. All questions in PASAPQ were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied. To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively: higher scores represent higher levels of satisfaction.

Time frame: At 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values are included.

According to Part 2 of the PASAPQ; willingness to continue is self-reported by the patient by providing a single value between 1 and 100. 0 indicates that the patient is not willing to continue using the inhaler and 100 indicates that the patient is definitely willing to continue.

Time frame: At 3 months after baseline.

Population: Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. Only subjects with both baseline and post baseline values are included.