Clinical trial NCT04402515: Tiotropium Plus Olodaterol vs Inhaled Corticosteroids (ICS) Regimens in the Portuguese Primary Care Setting (TIOLCOR Study)
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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?


Eligibility criteria: 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.

Primary outcomes:
measure: N of patients by education level
timeFrame: up to 4 months
measure: smoking status
timeFrame: up to 4 months
measure: BMI
timeFrame: up to 4 months
measure: N of patients by Portugal region
timeFrame: up to 4 months
measure: year of COPD diagnosis
timeFrame: up to 4 months
measure: comorbidities
timeFrame: up to 4 months
measure: GOLD 2019 group assessment
timeFrame: up to 4 months
measure: GOLD 2019 grade
timeFrame: up to 4 months
measure: blood eosinophil count
timeFrame: up to 4 months
measure: post-bronchodilator FEV1/FVC ratio (FEV1/FVC) ratio
timeFrame: up to 4 months
measure: FEV1 % predicted
timeFrame: up to 4 months
measure: number of COPD exacerbations
timeFrame: in the 12 months prior to the index date
measure: N of patients with pneumonia
timeFrame: up to 4 months
measure: Patient symptomatology according to the modified British Medical Research Council (mMRC) questionnaire
timeFrame: up to 4 months
measure: CAT score
timeFrame: up to 4 months
measure: Setting in which the COPD treatment was prescribed
timeFrame: up to 4 months
measure: Reasons for COPD treatment change
timeFrame: Index date
measure: Reasons for COPD treatment change between the index date and the inclusion visit
timeFrame: up to 4 months
Secondary outcomes:
measure: 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
timeFrame: Index date
measure: Patient Quality of Life according to EQ-5D-5L questionnaire
timeFrame: up to 4 months
measure: Overall patient satisfaction with inhaler device according to a 5-point Likert scale
timeFrame: up to 4 months
measure: Patient satisfaction with treatment according to Treatment Satisfaction Questionnaire for Medication
timeFrame: up to 4 months
Other outcomes:
Locations:
Study officials:
References: