Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical… (NCT03954132) | Clinical Trial Compass
CompletedNot Applicable
Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
Germany469 participantsStarted 2019-06-07
Plain-language summary
Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.
Who can participate
Age range40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 diagnos…
What they're measuring
1
Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation
Timeframe: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
2
Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)
Timeframe: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).