OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS)
NCT ID: NCT02719639
Last Updated: 2019-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
7443 participants
OBSERVATIONAL
2016-04-01
2017-05-31
Brief Summary
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Detailed Description
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Study Design:
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Female and male patients with more or equal to 40 years of age
3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto Respimat Summary of Product Characteristics (SmPC) and chronic obstructive pulmonary disease (COPD) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendation
Exclusion Criteria
2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
3. Patients continuing LABA- Inhalative Corticosteroids (ICS) treatment should not be additionally treated with Spiolto Respimat in order to avoid a double dosing of long-acting beta-agonists
4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
5. Pregnancy and lactation
6. Patients currently listed for lung transplantation
7. Current participation in any clinical trial or any other non-interventional study of a drug or device
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Multiple Locations, , Austria
Multiple Locations, , Czechia
Multiple Locations, , Hungary
Multiple Locations, , Israel
Multiple Locations, , Romania
Multiple Locations, , Russia
Multiple Locations, , Slovakia
Multiple Locations, , Slovenia
Multiple Locations, , Switzerland
Countries
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References
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Taube C, Bayer V, Zehendner CM, Valipour A. Assessment of Patient Experiences with Respimat(R) in Everyday Clinical Practice. Pulm Ther. 2020 Dec;6(2):371-380. doi: 10.1007/s41030-020-00127-4. Epub 2020 Aug 28.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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1237.44
Identifier Type: -
Identifier Source: org_study_id
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