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

Withdrawn

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: ICS; Drug: TIO/OLO

• Registration Number: NCT04402515
• Lead Sponsor: Boehringer Ingelheim

Brief 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?

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Study Start: 2021-10-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-05
• Primary Completion: 2022-01-15
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inhaled corticosteroids-containing treatment regimen	ICS	-
Tiotropium plus Olodaterol treatment regimen	TIO/OLO	-

Primary Outcome Measures

Name	Time	Method
N of patients by Portugal region	up to 4 months	regions: North, Center, Lisbon, Alentejo and Algarve (NUTS II)
year of COPD diagnosis	up to 4 months
BMI	up to 4 months
GOLD 2019 group assessment	up to 4 months	Global Initiative for Chronic Obstructive Lung Disease; groups A, B, C, D
GOLD 2019 grade	up to 4 months	Global Initiative for Chronic Obstructive Lung Disease; grades 1-4
N of patients by education level	up to 4 months
comorbidities	up to 4 months
smoking status	up to 4 months
blood eosinophil count	up to 4 months
post-bronchodilator FEV1/FVC ratio (FEV1/FVC) ratio	up to 4 months	FEV1: Forced expiratory volume in one second; FVC: Forced Vital Capacity
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	up to 4 months	CAT: COPD Assessment Test
Setting in which the COPD treatment was prescribed	up to 4 months	primary vs. hospital
Reasons for COPD treatment change	Index date	Index date is the prescription date of the new or initial COPD maintenance treatment.
Reasons for COPD treatment change between the index date and the inclusion visit	up to 4 months

Secondary Outcome Measures

Name	Time	Method
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	Index date is the prescription date of the new or initial COPD maintenance treatment.
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