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

Boehringer Ingelheim

Status: Withdrawn

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: TIO/OLO; Drug: ICS

Study type: Observational

Funder types: Industry

Identifiers

NCT04402515

1237-0096

Details and patient eligibility

About

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?

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged ≥ 40 years at the date of COPD diagnosis.
2. 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.
3. 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.
4. 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.

Trial design

0 participants in 2 patient groups

Tiotropium plus Olodaterol treatment regimen

Treatment:

Drug: TIO/OLO

Inhaled corticosteroids-containing treatment regimen

Treatment:

Drug: ICS