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

  • End date
    Sep 30, 2021
  • participants needed
  • sponsor
    Boehringer Ingelheim
Updated on 28 May 2021
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muscarinic antagonists


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


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.

Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease)
Treatment Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist, Tripple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist, Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids
Clinical Study IdentifierNCT03954132
SponsorBoehringer Ingelheim
Last Modified on28 May 2021


Yes No Not Sure

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
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