| Primary | Change From Baseline in Patients' Quality of Life (QoL) According to the Total Score of COPD Assessment Test (CAT) at Month 3 | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | At baseline and at 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
| | | Title | Denominators | Categories |
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| Baseline | | | | Change from baseline | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Score on a scale | -5.28 | | | 2-Sided | 95 | -5.67 | -4.89 | | | Least Square Mean for Visit, change from baseline (3 months - baseline) total CAT Score estimates. | | Other | Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the CAT score at each visit. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates. | |
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| Secondary | Percentage of Patients With CAT≥10 at Baseline and Month 3 | 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. | 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. | Posted | | Number | | Percentage of participants | | At baseline and at 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients - Baseline | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). Participants with non-missing baseline results were include in this group. | | OG001 | COPD Patients - Month 3 |
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| Secondary | Change From Baseline in the Total European Quality of Life-Visual Analogue Scale (EQ-VAS) at Month 3 | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | At baseline and at 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Percentage of Patients With Improved / Worsened Condition Mobility According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months | 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. | Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. | Posted | | Number | | Percentage of participants | | At baseline and at 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Percentage of Patients With Improved / Worsen Condition in Self-care According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months | 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. | Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. | Posted | | Number | | Percentage of participants | | At baseline and at 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Percentage of Patients With Improved / Worsen Condition Usual Activities According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months | 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. | Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. | Posted | | Number | | Percentage of participants | | At baseline and at 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Percentage of Patients With Improved / Worsen Condition Pain/Discomfort According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months | 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. | Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. | Posted | | Number | | Percentage of participants | | At baseline and at 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Percentage of Patients With Improved / Worsen Condition Anxiety/Depression According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months | 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. | Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®. | Posted | | Number | | Percentage of participants | | At baseline and at 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Percentage of Patients With Adherence to the Medication | 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. | 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. | Posted | | Number | | Percentage of participants | | At 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Total Score in Abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | At 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Overall Satisfaction of Inhaler | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | At 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Percentage of Patients by Preference for Inhaler | Percentage of patients by preference for inhaler according to Part 2 of the PASAPQ is reported. | 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. | Posted | | Number | | Percentage of participants | | At 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Willingness to Continue With Inhaler | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | At 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Change From Baseline of Patients' Dyspnea Status According to the Modified Medical Research Council (mMRC) Scale at Month 3 | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | At baseline and at 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch | Number of patients adherence to medication of COPD patients according to the Simplified Medication Adherence Questionnaire (SMAQ) three-months after the switch is reported. | 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. | Posted | | Count of Participants | | Participants | | At 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Number of Patients Per Medication Frequency Category According to Simplified Medication Adherence Questionnaire (SMAQ) | Number of patients per medication frequency category according to Simplified Medication Adherence Questionnaire (SMAQ) is reported. | 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. | Posted | | Count of Participants | | Participants | | At 3 months after baseline. | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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| Secondary | Days of Missed Medication for COPD | Days of missed medication for COPD is reported. | 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. | Posted | | Mean | Standard Deviation | days | | up to 3 months | | | | ID | Title | Description |
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| OG000 | COPD Patients | All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2). |
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