Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotr… (NCT04672941) | Clinical Trial Compass
CompletedNot Applicable
Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece
Greece1,396 participantsStarted 2021-02-16
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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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
âś“. Written informed consent prior to participation
âś“. Patient should be able to read, comprehend and complete study questionnaires
Exclusion criteria
✕. Patients with contraindications according to Spiolto® Respimat® SmPC
âś•. 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
✕. 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
âś•. Patients diagnosed with asthma or with asthma COPD overlap syndrome (ACO)
âś•. Patients for whom availability at the enrolling site during the planned study period of approximately 3 months is not possible
âś•. Pregnancy and lactation
âś•. Patients currently listed for lung transplantation
What they're measuring
1
Change From Baseline in Patients' Quality of Life (QoL) According to the Total Score of COPD Assessment Test (CAT) at Month 3
Timeframe: At baseline and at 3 months after baseline.