Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
NCT ID: NCT03003494
Last Updated: 2019-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
306 participants
OBSERVATIONAL
2017-06-06
2018-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Spiolto® Respimat®
consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC
Spiolto® Respimat®
observations taken in a period of approximately 6 weeks
Interventions
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Spiolto® Respimat®
observations taken in a period of approximately 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female and male patients = 40 years of age
3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and therapeutic plan 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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Ospedale Generale Regionale "Miulli"
Acquaviva Delle Fonti (BA), , Italy
Azienda Ospedaliera G. Rummo
Benevento, , Italy
Casa di cura Mons. Calaciura
Biancavilla, , Italy
Ospedale Orlandi
Bussolengo (VR), , Italy
IRCCS - Istituto Scientifico di Cassano delle Murge
Cassano Murge Bari, , Italy
Università degli Studi "Magna Grecia" - Campus "S. Venuta"
Catanzaro, , Italy
Ospedale Mellino Mellini
Chiari (BS), , Italy
Osp. Piero Palagi
Florence, , Italy
Ospedale Colonnello D Avanzo
Foggia, , Italy
A.O. Ospedale Guido Salvini
Garbagnate Milanese, , Italy
Presidio Ospedaliero di Imperia - ASL 1 Imperiese
Imperia, , Italy
Ospedale della Versilia
LIDO DI Camaiore (LU), , Italy
Ospedale S. Salvatore
L’Aquila, , Italy
Osp.dell'Angelo
Mestre, , Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Osp. dei Colli Monaldi-Cotugno
Napoli, , Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Ospedale S.Maria della Misericordia, AO di Perugia
Perugia, , Italy
Azienda Ospedali Riuniti Marche Nord
Pesaro, , Italy
Az.per Assist. Sanitaria N.5 Friuli Occidentale
Pordenone, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, , Italy
Università di Salerno
Salerno, , Italy
Presidio Ospedaliero di Sesto S. Giovanni ASST Nord Milano
Sesto San Giovanni (MI), , Italy
Fondazione Salvatore Maugeri
Tradate (VA), , Italy
Ospedale di Cattinara
Trieste, , Italy
Auxilium Vitae
Volterra, , Italy
Countries
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References
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Carone M, Pennisi A, D'Amato M, Donati AF, Ricci A, Scognamillo C, Chun L, Aliani M, Ronsivalle V, Pelaia G. Physical Functioning in Patients with Chronic Obstructive Pulmonary Disease Treated with Tiotropium/Olodaterol Respimat in Routine Clinical Practice in Italy. Pulm Ther. 2020 Dec;6(2):261-274. doi: 10.1007/s41030-020-00122-9. Epub 2020 Jun 18.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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1237.43
Identifier Type: -
Identifier Source: org_study_id
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