Clareo Health | Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
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.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
