Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Spiolto® Respimat®; Drug: Triple-Therapy (LAMA/LABA/ICS)

Study type: Observational

Funder types: Industry

Identifiers

NCT03954132

1237-0087

Details and patient eligibility

About

Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.

Full description

COPD patients on LABA/ICS maintenance therapy with dyspnea (mMRC ≥ 1) and other symptoms (CATTM ≥ 10), who are switched to either Spiolto® Respimat® in the new reusable inhaler or any triple therapy (LAMA + LABA + ICS) as an open or fixed combination according to approved SmPCs at baseline at the discretion of their attending physician.

Enrollment: 469 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients can be included if all of the following criteria are met:

• Diagnosis of COPD
• Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time)
• Patients on LABA/ICS maintenance therapy who are switched to Spiolto® Respimat® in the new reusable inhaler or a free/fixed triple combination of LABA + LAMA + ICS at Visit 1 at the discretion of the treating physician.
• Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
• Male or female
• Patients aged ≥40 years of age
• Written informed consent prior to study participation
• The patient is willing and able to follow the procedures outlined in the protocol

Exclusion criteria

• Patients with contraindications acc. to SmPC
• Patients not on LABA/ICS maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ICS only, or a triple combination of LAMA + LABA + ICS (either as a fixed combination product or as separate components)
• Lack of informed consent
• Pregnant and/or lactating females
• Acute exacerbation of COPD (within 4 weeks prior to Visit 1)
• Frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months
• Acute respiratory failure (pH <7,35 and/ or respiratory rate >30/min within 3 months prior to Visit 1)
• History or current diagnosis of asthma
• History or current diagnosis of asthma-COPD overlap
• History or current diagnosis of allergic rhinitis within the last 5 years
• History or current diagnosis of lung cancer within the last 5 years
• Participation in a parallel interventional clinical trial
• mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician
• moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic
• severe exacerbation: exacerbation leading to hospitalization

Trial design

469 participants in 2 patient groups

Spiolto® Respimat®

Description:

Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.

Treatment:

Drug: Spiolto® Respimat®

Triple-Therapy (LAMA/LABA/ICS)

Description:

Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.

Treatment:

Drug: Triple-Therapy (LAMA/LABA/ICS)