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
262 participants
OBSERVATIONAL
2019-09-30
2020-02-13
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.
Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease
NCT01019694
Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
NCT00400153
Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease
NCT02157935
Assessment of Health-related Quality of Life After Switching COPD Patients From a Dry Powder Inhaler to a Soft Mist Inhaler Remaining on the Same Inhalative Drug
NCT05362487
Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00153075
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.
Respimat SMI-experienced: Switching to re-usable Respimat
patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry.
Respimat
Soft Mist Inhaler product
Respimat SMI-naïve
patients who have not previously used a Respimat SMI product and receive their first prescription at study entry
Respimat
Soft Mist Inhaler product
Respimat SMI-experienced: Maintenance treatment
patients who have been on maintenance treatment with a Respimat SMI product and receive a refill prescription at study entry.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Respimat
Soft Mist Inhaler product
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
* Patient with COPD aged 40 years or older
* Patient prescribed (or already receiving the disposable Respimat SMI and switched to) one of the following re-usable Respimat SMI products per the standard clinical practice: Spiriva 2.5 microgram inhalation solution; (2) Striverdi 2.5 microgram inhalation solution; and (3) Spiolto 2.5 microgram / 2.5 microgram inhalation solution
* Patient unlikely to change their Respimat therapy during the 4-6 week observation period (in the opinion of the investigator)
Exclusion Criteria
* Patient who have had a severe COPD exacerbation requiring hospitalisation in the immediate 3 months prior to study entry
* Patient participating in a clinical trial or any other non-interventional study of a drug or device at the time of enrolment
* Visual, cognitive, motor or health impairment that, as judged by the investigator, may cause concern regarding the patient's ability to complete the questionnaires
* Patient not fluent and literate in one of the main languages of the country
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.
Brussels - UNIV UZ Brussel
Brussels, , Belgium
Clinique Notre-Dame de Grâce
Gosselies, , Belgium
Roeselare - HOSP AZ Delta
Menen, , Belgium
Hvidovre Hospital
Hvidovre, , Denmark
Vejle Hospital
Vejle, , Denmark
TYKS, Keuhkosairauksien klinikka, Turku
Turku, , Finland
Universitätsklinikum Aachen, AöR
Aachen, , Germany
MECS Research GmbH, Berlin
Berlin, , Germany
KPPK GmbH, Studienzentrum
Koblenz, , Germany
Pneumologiezentrum Leipzig
Leipzig, , Germany
Pneumologische Schwerpunktpraxis, 23558 Lübeck
Lübeck, , Germany
Amphia Ziekenhuis
Breda, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Franciscus Gasthuis
Rotterdam, , Netherlands
Gelre Ziekenhuis Zutphen
Zutphen, , Netherlands
Frisk Utvikling Helse AS
Elverum, , Norway
Hisøy Legesenter
Kolbjørnsvik, , Norway
Lambertseter Legesenter
Oslo, , Norway
Svelvik Legesenter
Svelvik, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1237-0097
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.