Trial Outcomes & Findings for Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece (NCT NCT04672941)
NCT ID: NCT04672941
Last Updated: 2024-06-25
Results Overview
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.
COMPLETED
1396 participants
At baseline and at 3 months after baseline.
2024-06-25
Participant Flow
This non-interventional study (NIS) was to evaluate changes within 3 months in quality of life according to health status evaluated with the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test in 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.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
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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|---|---|
|
Overall Study
STARTED
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1396
|
|
Overall Study
COMPLETED
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1388
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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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|---|---|
|
Overall Study
Investigator decision
|
1
|
|
Overall Study
Treatment with Spiolto® Respimat® discontinuation
|
2
|
|
Overall Study
COVID-19 related but no adverse event
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
COPD Patients
n=1396 Participants
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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|---|---|
|
Age, Continuous
|
68.48 Years
STANDARD_DEVIATION 9.670 • n=1396 Participants
|
|
Sex: Female, Male
Female
|
429 Participants
n=1396 Participants
|
|
Sex: Female, Male
Male
|
967 Participants
n=1396 Participants
|
PRIMARY outcome
Timeframe: 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 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.
Outcome measures
| Measure |
COPD Patients
n=1342 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
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|---|---|---|
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Change From Baseline in Patients' Quality of Life (QoL) According to the Total Score of COPD Assessment Test (CAT) at Month 3
Baseline
|
18.41 Score on a scale
Standard Deviation 6.967
|
—
|
|
Change From Baseline in Patients' Quality of Life (QoL) According to the Total Score of COPD Assessment Test (CAT) at Month 3
Change from baseline
|
-5.25 Score on a scale
Standard Deviation 6.281
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
COPD Patients
n=1396 Participants
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).
|
COPD Patients - Month 3
n=1364 Participants
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 results at 3 months after baseline were include in this group.
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|---|---|---|
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Percentage of Patients With CAT≥10 at Baseline and Month 3
|
91.76 Percentage of participants
|
66.12 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1333 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
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|---|---|---|
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Change From Baseline in the Total European Quality of Life-Visual Analogue Scale (EQ-VAS) at Month 3
|
11.44 Score on a scale
Standard Deviation 13.225
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1396 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
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|---|---|---|
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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
Improvement compared to baseline
|
44.27 Percentage of participants
|
—
|
|
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
Deterioration compared to baseline
|
2.87 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1396 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
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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
Improvement compared to baseline
|
30.59 Percentage of participants
|
—
|
|
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
Deterioration compared to baseline
|
3.80 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1396 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
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|---|---|---|
|
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
Improvement compared to baseline
|
43.62 Percentage of participants
|
—
|
|
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
Deterioration compared to baseline
|
4.08 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1396 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
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
Improvement compared to baseline
|
43.55 Percentage of participants
|
—
|
|
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
Deterioration compared to baseline
|
4.87 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 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 anxiety/depression is reported in this endpoint.
Outcome measures
| Measure |
COPD Patients
n=1396 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
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
Improvement compared to baseline
|
43.27 Percentage of participants
|
—
|
|
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
Deterioration compared to baseline
|
4.01 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1323 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
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|---|---|---|
|
Percentage of Patients With Adherence to the Medication
Yes
|
67.20 Percentage of participants
|
—
|
|
Percentage of Patients With Adherence to the Medication
No
|
32.80 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
COPD Patients
n=1364 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
Total Score in Abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ)
|
78.74 Score on a scale
Standard Deviation 10.845
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
COPD Patients
n=1364 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
Overall Satisfaction of Inhaler
|
6.15 Score on a scale
Standard Deviation 0.905
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1356 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
Percentage of Patients by Preference for Inhaler
No preference
|
8.85 Percentage of participants
|
—
|
|
Percentage of Patients by Preference for Inhaler
Spiriva® Handihaler®
|
4.06 Percentage of participants
|
—
|
|
Percentage of Patients by Preference for Inhaler
Spiolto® Respimat®
|
87.09 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1356 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
Willingness to Continue With Inhaler
|
88.39 Score on a scale
Standard Deviation 14.207
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1304 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
Change From Baseline of Patients' Dyspnea Status According to the Modified Medical Research Council (mMRC) Scale at Month 3
|
-0.55 Score on a scale
Standard Deviation 0.776
|
—
|
SECONDARY outcome
Timeframe: 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 adherence to medication of COPD patients according to the Simplified Medication Adherence Questionnaire (SMAQ) three-months after the switch is reported.
Outcome measures
| Measure |
COPD Patients
n=1356 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
At the last weekend, did you miss your medication? · Yes
|
53 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
At the last weekend, did you miss your medication? · No
|
1263 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
At the last weekend, did you miss your medication? · Missing
|
40 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
Forget to take the medication for COPD · Yes
|
154 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
Forget to take the medication for COPD · No
|
1162 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
Forget to take the medication for COPD · Missing
|
40 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
Always take your medication for COPD at the indicated time · Yes
|
1030 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
Always take your medication for COPD at the indicated time · No
|
286 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
Always take your medication for COPD at the indicated time · Missing
|
40 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
If feel worse, do you stop taking the medication for COPD? · Yes
|
41 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
If feel worse, do you stop taking the medication for COPD? · No
|
1275 Participants
|
—
|
|
Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
If feel worse, do you stop taking the medication for COPD? · Missing
|
40 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
COPD Patients
n=1356 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
Number of Patients Per Medication Frequency Category According to Simplified Medication Adherence Questionnaire (SMAQ)
1-2 times
|
201 Participants
|
—
|
|
Number of Patients Per Medication Frequency Category According to Simplified Medication Adherence Questionnaire (SMAQ)
3-5 times
|
16 Participants
|
—
|
|
Number of Patients Per Medication Frequency Category According to Simplified Medication Adherence Questionnaire (SMAQ)
6-10 times
|
4 Participants
|
—
|
|
Number of Patients Per Medication Frequency Category According to Simplified Medication Adherence Questionnaire (SMAQ)
Never
|
1095 Participants
|
—
|
|
Number of Patients Per Medication Frequency Category According to Simplified Medication Adherence Questionnaire (SMAQ)
Missing
|
40 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 3 monthsPopulation: 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.
Days of missed medication for COPD is reported.
Outcome measures
| Measure |
COPD Patients
n=1356 Participants
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).
|
COPD Patients - Month 3
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 results at 3 months after baseline were include in this group.
|
|---|---|---|
|
Days of Missed Medication for COPD
|
1.55 days
Standard Deviation 4.330
|
—
|
Adverse Events
COPD Patients
Serious adverse events
| Measure |
COPD Patients
n=1396 participants at risk
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).
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.14%
2/1396 • From baseline up to 3 months after baseline.
Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.07%
1/1396 • From baseline up to 3 months after baseline.
Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®.
|
|
Infections and infestations
COVID-19
|
0.07%
1/1396 • From baseline up to 3 months after baseline.
Treated Set (TS): All patients who were enrolled in the study and have received at least one dose of Spiolto® Respimat®.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER