The primary objective of this non-interventional study (NIS) is to evaluate changes within 3 months in quality of life according to health status evaluated with the COPD Assessment Test (CAT) in COPD patients who have 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.
Study Type
OBSERVATIONAL
Enrollment
1,396
Tiotropium bromide plus Olodaterol
Metropolitan Hospitsal, PNOI Pulmonology Clinic
Athens, Greece
European Interbalkan Medical Center, Pulmonology Clinic
Thessaloniki, Greece
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.
Time frame: At baseline and at 3 months after baseline.
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.
Time frame: At baseline and at 3 months after baseline.
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.
Time frame: At baseline and at 3 months after baseline.
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.
Time frame: At baseline and at 3 months after baseline.
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.
Time frame: At baseline and at 3 months after baseline.
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.
Time frame: At baseline and at 3 months after baseline.
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.
Time frame: At baseline and at 3 months after baseline.
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.
Time frame: At baseline and at 3 months after baseline.
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.
Time frame: At 3 months after baseline.
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.
Time frame: At 3 months after baseline.
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.
Time frame: At 3 months after baseline.
Percentage of Patients by Preference for Inhaler
Percentage of patients by preference for inhaler according to Part 2 of the PASAPQ is reported.
Time frame: At 3 months after baseline.
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.
Time frame: At 3 months after baseline.
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.
Time frame: At baseline and at 3 months after baseline.
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.
Time frame: At 3 months after baseline.
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.
Time frame: At 3 months after baseline.
Days of Missed Medication for COPD
Days of missed medication for COPD is reported.
Time frame: up to 3 months
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