Tiotropium Plus Olodaterol vs Inhaled Corticosteroids (ICS) Regimens in the Portuguese Primary Care Setting (TIOLCOR Study)

Study Overview
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Brief Summary
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What are the differences between patients prescribed a new maintenance treatment for Chronic Obstructive Pulmonary Disease (COPD) with tiotropium/olodaterol (TIO/OLO) or Inhaled Corticosteroids (ICS)-containing regimens in terms of sociodemographic, anthropometric and clinical characteristics?

Official Title
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Preferences and Consequences in Therapy Decision-making: Tiotropium Bromide Plus Olodaterol vs ICS-containing Regimens in COPD Patients in the Portuguese Primary Care Setting: an Observational, Cross-sectional Study

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: TIO/OLO
* Drug: ICS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 40 years at the date of COPD diagnosis. Diagnosis of COPD confirmed by the investigator. A spirometry confirming the diagnosis (FEV1/forced vital capacity [FVC] ratio <0.7) and performed within the three years prior to the inclusion visit must be available in the patient's medical records. Prescription of a new maintenance COPD treatment with TIO/OLO or ICS-containing regimens (not including TIO/OLO) 3 months (-7/+30 days) prior to the inclusion visit. The COPD treatment may have been prescribed at primary care sites or at the hospital. Written informed consent prior to participation. Exclusion Criteria: 1. Respiratory disorders other than COPD, such as asthma-COPD overlap or asthma (prior to or at the index date). 2a. For treatment naïve patients (i.e., those who have never started a maintenance therapy for COPD [with either short- or long-acting bronchodilators or ICS]) - no data on the GOLD 2019 group at the index date is available in the medical records. Patients may still be included if the determination of the GOLD 2019 group is possible based on the medical records' data and/or patient interviews (e.g. by using information on exacerbation history in the 12 months prior to the index date, and data on mMRC and COPD Assessment Test (CAT) at the index date). 2b. For treatment experienced patients - no data on the predominant treatable trait to target at the index date (dyspnea, exacerbation or both) is available in the medical records. Patients may still be included if this information is obtained based on patient interviews. 3. Participation in a clinical trial within the 3 months prior to the inclusion visit.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tiotropium plus Olodaterol treatment regimen<br> | Drug: TIO/OLO<br>* Tiotropium/Olodaterol<br>|
| Inhaled corticosteroids-containing treatment regimen<br> | Drug: ICS<br>* inhaled cortocosteroids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N of patients by education level |  | up to 4 months | 
| smoking status |  | up to 4 months | 
| BMI |  | up to 4 months | 
| N of patients by Portugal region | regions: North, Center, Lisbon, Alentejo and Algarve (NUTS II) | up to 4 months | 
| year of COPD diagnosis |  | up to 4 months | 
| comorbidities |  | up to 4 months | 
| GOLD 2019 group assessment | Global Initiative for Chronic Obstructive Lung Disease; groups A, B, C, D | up to 4 months | 
| GOLD 2019 grade | Global Initiative for Chronic Obstructive Lung Disease; grades 1-4 | up to 4 months | 
| blood eosinophil count |  | up to 4 months | 
| post-bronchodilator FEV1/FVC ratio (FEV1/FVC) ratio | FEV1: Forced expiratory volume in one second; FVC: Forced Vital Capacity | up to 4 months | 
| FEV1 % predicted |  | up to 4 months | 
| number of COPD exacerbations |  | in the 12 months prior to the index date | 
| N of patients with pneumonia |  | up to 4 months | 
| Patient symptomatology according to the modified British Medical Research Council (mMRC) questionnaire |  | up to 4 months | 
| CAT score | CAT: COPD Assessment Test | up to 4 months | 
| Setting in which the COPD treatment was prescribed | primary vs. hospital | up to 4 months | 
| Reasons for COPD treatment change | Index date is the prescription date of the new or initial COPD maintenance treatment. | Index date | 
| Reasons for COPD treatment change between the index date and the inclusion visit |  | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients for whom the new COPD treatment is in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Guideline recommendations | Index date is the prescription date of the new or initial COPD maintenance treatment. | Index date | 
| Patient Quality of Life according to EQ-5D-5L questionnaire |  | up to 4 months | 
| Overall patient satisfaction with inhaler device according to a 5-point Likert scale |  | up to 4 months | 
| Patient satisfaction with treatment according to Treatment Satisfaction Questionnaire for Medication |  | up to 4 months |