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

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

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?

Study Overview

• Status: Withdrawn
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: TIO/OLO; Drug: ICS

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The source population are COPD patients starting a new maintenance COPD treatment with TIO/OLO or with an ICS-containing regimen in the primary care setting.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tiotropium plus Olodaterol treatment regimen	Drug: TIO/OLO; Tiotropium/Olodaterol
Inhaled corticosteroids-containing treatment regimen	Drug: ICS; inhaled cortocosteroids

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): October 28, 2021
• Primary Completion (Anticipated): January 15, 2022
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1237-0096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder;
2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No