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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1396 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-16

Study Completion Date

2022-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD patients

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).

Tiotropium bromide plus Olodaterol

Intervention Type DRUG

Tiotropium bromide plus Olodaterol

Interventions

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Tiotropium bromide plus Olodaterol

Intervention Type DRUG

Other Intervention Names

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(Spiolto® Respimat®)

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No