Clinical trial NCT04672941: Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece
Official title: Quality of Life and Preference of COPD Patients After Switching From Tiotropium Monotherapy (Spiriva® Handihaler®) to Dual Therapy With Tiotropium Bromide Plus Olodaterol (Spiolto® Respimat®) Under Real Life Conditions in Greece (ELLACTO II Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 1396
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 1500 patients with chronic obstructive pulmonary disease (COPD) who have recently switched (within one week) from Spiriva® Handihaler® to Spiolto® Respimat® according to the daily clinical practice in the corresponding site, are to be observed.

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Female and male patients ≥40 years of age
2. 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
3. Written informed consent prior to participation
4. Patient should be able to read, comprehend and complete study questionnaires

Exclusion Criteria:

1. Patients with contraindications according to Spiolto® Respimat® SmPC
2. 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
3. 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
4. Patients diagnosed with asthma or with asthma COPD overlap syndrome (ACO)
5. Patients for whom availability at the enrolling site during the planned study period of approximately 3 months is not possible
6. Pregnancy and lactation
7. Patients currently listed for lung transplantation
8. Current participation in any clinical trial or any other non-interventional study of a drug or device.

Further exclusion criteria apply.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Percentage of Patients With CAT≥10 at Baseline and Month 3
timeFrame: At baseline and at 3 months after baseline.
measure: Change From Baseline in the Total European Quality of Life-Visual Analogue Scale (EQ-VAS) at Month 3
timeFrame: At baseline and at 3 months after baseline.
measure: 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
timeFrame: At baseline and at 3 months after baseline.
measure: 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
timeFrame: At baseline and at 3 months after baseline.
measure: 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
timeFrame: At baseline and at 3 months after baseline.
measure: 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
timeFrame: At baseline and at 3 months after baseline.
measure: 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
timeFrame: At baseline and at 3 months after baseline.
measure: Percentage of Patients With Adherence to the Medication
timeFrame: At 3 months after baseline.
measure: Total Score in Abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ)
timeFrame: At 3 months after baseline.
measure: Overall Satisfaction of Inhaler
timeFrame: At 3 months after baseline.
measure: Percentage of Patients by Preference for Inhaler
timeFrame: At 3 months after baseline.
measure: Willingness to Continue With Inhaler
timeFrame: At 3 months after baseline.
measure: Change From Baseline of Patients' Dyspnea Status According to the Modified Medical Research Council (mMRC) Scale at Month 3
timeFrame: At baseline and at 3 months after baseline.
measure: Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch
timeFrame: At 3 months after baseline.
measure: Number of Patients Per Medication Frequency Category According to Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: At 3 months after baseline.
measure: Days of Missed Medication for COPD
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Metropolitan Hospitsal, PNOI Pulmonology Clinic
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center, Pulmonology Clinic
Study officials:
affiliation: maria.katsamani.ext@boehringer-ingelheim.com
name: Maria Katsamani, +30 210 8906 108
role: STUDY_CHAIR
References: