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

NCT04402515 | Withdrawn FDA Drug

• 1 other identifier: 1237-0096
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (4)

• 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

• 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

Study Arms (2)

Tiotropium plus Olodaterol treatment regimen

Drug: TIO/OLO

Inhaled corticosteroids-containing treatment regimen

Drug: ICS

Interventions

TIO/OLO DRUG

Tiotropium/Olodaterol

Tiotropium plus Olodaterol treatment regimen

ICS DRUG

inhaled cortocosteroids

Inhaled corticosteroids-containing treatment regimen

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged ≥ 40 years at the date of COPD diagnosis.
• Written informed consent prior to participation.

You may not qualify if:

• \. Respiratory disorders other than COPD, such as asthma-COPD overlap or asthma (prior to or at the index date).
• a. 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).
• b. 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 27, 2020
• Study Start: October 28, 2021
• Primary Completion: January 15, 2022
• Study Completion: January 31, 2022
• Last Updated: November 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share