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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04402515
• Other study ID #: 1237-0096
• Status: Withdrawn
• Start date: October 28, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• TIO/OLO
Tiotropium/Olodaterol
• ICS
inhaled cortocosteroids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N of patients by education level		up to 4 months
Primary	smoking status		up to 4 months
Primary	BMI		up to 4 months
Primary	N of patients by Portugal region	regions: North, Center, Lisbon, Alentejo and Algarve (NUTS II)	up to 4 months
Primary	year of COPD diagnosis		up to 4 months
Primary	comorbidities		up to 4 months
Primary	GOLD 2019 group assessment	Global Initiative for Chronic Obstructive Lung Disease; groups A, B, C, D	up to 4 months
Primary	GOLD 2019 grade	Global Initiative for Chronic Obstructive Lung Disease; grades 1-4	up to 4 months
Primary	blood eosinophil count		up to 4 months
Primary	post-bronchodilator FEV1/FVC ratio (FEV1/FVC) ratio	FEV1: Forced expiratory volume in one second; FVC: Forced Vital Capacity	up to 4 months
Primary	FEV1 % predicted		up to 4 months
Primary	number of COPD exacerbations		in the 12 months prior to the index date
Primary	N of patients with pneumonia		up to 4 months
Primary	Patient symptomatology according to the modified British Medical Research Council (mMRC) questionnaire		up to 4 months
Primary	CAT score	CAT: COPD Assessment Test	up to 4 months
Primary	Setting in which the COPD treatment was prescribed	primary vs. hospital	up to 4 months
Primary	Reasons for COPD treatment change	Index date is the prescription date of the new or initial COPD maintenance treatment.	Index date
Primary	Reasons for COPD treatment change between the index date and the inclusion visit		up to 4 months
Secondary	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
Secondary	Patient Quality of Life according to EQ-5D-5L questionnaire		up to 4 months
Secondary	Overall patient satisfaction with inhaler device according to a 5-point Likert scale		up to 4 months
Secondary	Patient satisfaction with treatment according to Treatment Satisfaction Questionnaire for Medication		up to 4 months

External Links

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