Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium bromide plus Olodaterol

Study type: Observational

Funder types: Industry

Identifiers

NCT04672941

1237-0098

Details and patient eligibility

About

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.

Enrollment: 1,396 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,396 participants in 1 patient group

COPD patients

Description:

COPD patients switching from Tiotropium monotherapy to dual therapy with Tiotropium bromide plus Olodaterol. 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 were visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2).

Treatment:

Drug: Tiotropium bromide plus Olodaterol