N/A
Completed N=463
Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT03954132 ↗
Enrolled (actual)
463
Serious AEs
0.2%
Results posted
Mar 2024
Primary outcomePrimary: Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation — 0.23; 0.25 Change in score on a scale
Summary
Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation |
0.23; 0.25 | — |
| PRIMARY Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment) |
3.45; 2.51 | — |
| SECONDARY Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline |
0; 0; 3; 4; 17; 26 | — |
| SECONDARY Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period |
0; 1; 3; 3; 9; 18 | — |
| SECONDARY Patient Satisfaction With Inhaler and Therapy at End of Observation Period |
31; 17; 58; 21; 7; 7 | — |
| SECONDARY Number of Responders With Δ mMRC≥ 1 |
83; 92; 28; 26; 1; 1 | — |
| SECONDARY Number of Responders With Δ CAT≥ 2 |
35; 51; 76; 67; 1; 1 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03954132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.