N/A
Completed N=1,396
Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04672941 ↗
Enrolled (actual)
1,396
Serious AEs
0.1%
Results posted
Nov 2023
Primary outcomePrimary: Change From Baseline in Patients' Quality of Life (QoL) According to the Total Score of COPD Assessment Test (CAT) at Month 3 — 18.41; -5.25 Score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Patients' Quality of Life (QoL) According to the Total Score of COPD Assessment Test (CAT) at Month 3 |
18.41; -5.25 | — |
| SECONDARY Percentage of Patients With CAT≥10 at Baseline and Month 3 |
91.76; 66.12 | < 0.001 sig |
| SECONDARY Change From Baseline in the Total European Quality of Life-Visual Analogue Scale (EQ-VAS) at Month 3 |
11.44 | — |
| 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 |
44.27; 2.87 | < 0.001 sig |
| 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 |
30.59; 3.80 | < 0.001 sig |
| 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 |
43.62; 4.08 | < 0.001 sig |
| 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 |
43.55; 4.87 | < 0.001 sig |
| 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 |
43.27; 4.01 | < 0.001 sig |
| SECONDARY Percentage of Patients With Adherence to the Medication |
67.20; 32.80 | — |
| SECONDARY Total Score in Abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) |
78.74 | — |
| SECONDARY Overall Satisfaction of Inhaler |
6.15 | — |
| SECONDARY Percentage of Patients by Preference for Inhaler |
4.06; 87.09; 8.85 | — |
| SECONDARY Willingness to Continue With Inhaler |
88.39 | — |
| SECONDARY Change From Baseline of Patients' Dyspnea Status According to the Modified Medical Research Council (mMRC) Scale at Month 3 |
-0.55 | — |
| SECONDARY Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch |
154; 1162; 40; 1030; 286; 40 | — |
| SECONDARY Number of Patients Per Medication Frequency Category According to Simplified Medication Adherence Questionnaire (SMAQ) |
1095; 201; 16; 4; 40 | — |
| SECONDARY Days of Missed Medication for COPD |
1.55 | — |
Eligibility Criteria
Inclusion Criteria
- Female and male patients ≥40 years of age
- Patients diagnosed with COPD who have been using tiotropium administered with Spiriva® Handihaler® for at least 3 months before a recent switch (within last week) to a combination therapy with tiotropium bromide plus olodaterol administered with Spiolto® Respimat® has been made
- Written informed consent prior to participation
- Patient should be able to read, comprehend and complete study questionnaires
Exclusion Criteria
- Patients with contraindications according to Spiolto® Respimat® SmPC
- Patients who have been treated with inhaled corticosteroids (ICS) as maintenance therapy* or with a Long-acting beta2 adrenoceptor agonist (LABA)/Long-acting muscarinic antagonist (LAMA) combination (free or fixed dose) in the previous 6 weeks
*Note: patients with temporary corticosteroids (CS) use during acute exacerbations in the previous 6 weeks can enter the study
- Patients who have been treated with Spiriva® Respimat®, with other LAMA different than Spiriva®, or with a combination of Spiriva®+LABA/ICS in the previous 6 weeks
- Patients diagnosed with asthma or with asthma COPD overlap syndrome (ACO)
- Patients for whom availability at the enrolling site during the planned study period of approximately 3 months is not possible
- Pregnancy and lactation
- Patients currently listed for lung transplantation
- Current participation in any clinical trial or any other non-interventional study of a drug or device.
Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT04672941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.