Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1360 participants
OBSERVATIONAL
2018-03-19
2019-04-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece
NCT04672941
Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
NCT03003494
Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
NCT03954132
A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler
NCT03663569
Clinical Study for the Effectiveness of Roflumilast Treatment in COPD Greek Patients Based on Standard Clinical Practice.
NCT05426915
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
COPD patients
Chronic obstructive pulmonary disease
MaxSpiolto® Respimat® 160 Characters...
as per the approved SmPC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MaxSpiolto® Respimat® 160 Characters...
as per the approved SmPC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female and male patients ≥40 years of age
* Treatment with Spiolto ® Respimat® acc. to SmPC and at the discretion of the physician
* Written informed consent prior to participation
Exclusion Criteria
* Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 weeks or patients already on a combination of LAMA and LABA therapy; either as a fixed combination product or as separate components Note: Patients previously treated with LABA or LAMA (with or without ICS) are eligible to be included in the study
* Patients continuing LABA-ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
* Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
* Pregnancy and lactation
* Patients currently listed for lung transplantation
* Current participation in any clinical trial or any other non-interventional study of a drug or device
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Metropolitan
Aegina, , Greece
Metroplitan
Athens, , Greece
Metropolitan
Athens, , Greece
Metropolitan
Chania, , Greece
Metropolitan
Heraklio, , Greece
Metropolitan
Hrakleio, , Greece
Metropolitan
Hraklio, , Greece
Diavalkaniko
Ioannina, , Greece
Diavalkaniko
Kavala, , Greece
Diavalkaniko
Larissa, , Greece
Metropolitan
Pátrai, , Greece
Diavalkaniko
Serres, , Greece
Merkouropoulos Markos
Thessaloniki, , Greece
Diavalkaniko
Thessaloniki, , Greece
Diavalkaniko
Volos, , Greece
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kosmas E, Titopoulos I, Patentalakis G, Nikas N. An Observational Study Assessing Changes in Health and Functional Status in Patients with Chronic Obstructive Pulmonary Disease (COPD) During Therapy with Spiolto(R) Respimat(R) in Everyday Clinical Practice: The Greek ELLACTO Study. Pulm Ther. 2021 Dec;7(2):429-443. doi: 10.1007/s41030-021-00156-7. Epub 2021 May 3.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1237-0073
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.