Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece

NCT04672941 | Completed Results FDA Drug

• 1 other identifier: 1237-0098
• Study Type: observational
• Target: 1,396
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this non-interventional study (NIS) is to evaluate changes within 3 months in quality of life according to health status evaluated with the COPD Assessment Test (CAT) in COPD patients who have recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Patients' Quality of Life (QoL) According to the Total Score of COPD Assessment Test (CAT) at Month 3

  The CAT is a patient-completed questionnaire assessing globally the impact of COPD on health status. It contains 8 items, where each item has a score range from 0 to 5. The CAT score is calculated by summing up the scores from the 8 items. CAT score ranges from 0 to 40. Higher score denotes a more severe impact of COPD on a patient's life. CAT score \<10 corresponding to mild impact on patients life is usually considered representing patients without impaired health status.

  At baseline and at 3 months after baseline.

Secondary Outcomes (16)

• Percentage of Patients With CAT≥10 at Baseline and Month 3

  At baseline and at 3 months after baseline.

• Change From Baseline in the Total European Quality of Life-Visual Analogue Scale (EQ-VAS) at Month 3

  At baseline and at 3 months after baseline.

• Percentage of Patients With Improved / Worsened Condition Mobility According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months

  At baseline and at 3 months after baseline.

• Percentage of Patients With Improved / Worsen Condition in Self-care According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months

  At baseline and at 3 months after baseline.

• Percentage of Patients With Improved / Worsen Condition Usual Activities According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months

  At baseline and at 3 months after baseline.

Study Arms (1)

COPD patients

COPD patients switching from Tiotropium monotherapy to dual therapy with Tiotropium bromide plus Olodaterol. All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants were visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2).

Drug: Tiotropium bromide plus Olodaterol

Interventions

Tiotropium bromide plus Olodaterol DRUG

Tiotropium bromide plus Olodaterol

Also known as: (Spiolto® Respimat®)

COPD patients

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

Approximately 1500 patients with chronic obstructive pulmonary disease (COPD) who have recently switched (within one week) from Spiriva® Handihaler® to Spiolto® Respimat® according to the daily clinical practice in the corresponding site, are to be observed.

You may qualify if:

• Female and male patients ≥40 years of age
• Patients diagnosed with COPD who have been using tiotropium administered with Spiriva® Handihaler® for at least 3 months before a recent switch (within last week) to a combination therapy with tiotropium bromide plus olodaterol administered with Spiolto® Respimat® has been made
• Written informed consent prior to participation
• Patient should be able to read, comprehend and complete study questionnaires

You may not qualify if:

• Patients with contraindications according to Spiolto® Respimat® SmPC
• Patients who have been treated with inhaled corticosteroids (ICS) as maintenance therapy\* or with a Long-acting beta2 adrenoceptor agonist (LABA)/Long-acting muscarinic antagonist (LAMA) combination (free or fixed dose) in the previous 6 weeks
• \*Note: patients with temporary corticosteroids (CS) use during acute exacerbations in the previous 6 weeks can enter the study
• Patients who have been treated with Spiriva® Respimat®, with other LAMA different than Spiriva®, or with a combination of Spiriva®+LABA/ICS in the previous 6 weeks
• Patients diagnosed with asthma or with asthma COPD overlap syndrome (ACO)
• Patients for whom availability at the enrolling site during the planned study period of approximately 3 months is not possible
• Pregnancy and lactation
• Patients currently listed for lung transplantation
• Current participation in any clinical trial or any other non-interventional study of a drug or device.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

Metropolitan Hospitsal, PNOI Pulmonology Clinic

Athens, 185 47, Greece

Location

European Interbalkan Medical Center, Pulmonology Clinic

Thessaloniki, 555 35, Greece

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; olodaterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Maria Katsamani, +30 210 8906 108

  maria.katsamani.ext@boehringer-ingelheim.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 17, 2020
• Study Start: February 16, 2021
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: June 25, 2024
• Results First Posted: November 28, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

GR (2)