A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Changes in Clinical Control of COPD Patients Measured by the Clinical COPD Questionnaire During Therapy With Spiolto®Respimat® in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663569
• Other study ID #: 1237-0072
• Status: Completed
• Start date: August 15, 2018
• Est. completion date: October 4, 2019

Study information

• Verified date: September 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4819
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent prior to participation

• Female and male patients =40 years of age

• Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines

Exclusion Criteria:

• Patients with contraindications according to Spiolto® Respimat® SmPC

• Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry

• 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

• Pregnancy and lactation

• Current participation in any clinical trial or any other non-interventional study of a drug or device.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Spiolto® Respimat®
Drug

Locations

Country	Name	City	State
Bulgaria	MBAL Sveti Ivan Rilski-2003	Dupnitza
Bulgaria	SBALBB "Pencho Semov" - Gabrovo EOOD	Gabrovo
Bulgaria	SBALPFZ Haskovo EOOD	Haskovo
Bulgaria	MBAL Kiro Popov EOOD	Karlovo
Bulgaria	MBAL Sv. Ivan Rilski EOOD	Kozloduj
Bulgaria	MBAL "Prof. Dr P. Stoyanov" AD - Mihail Kirov	Lovech
Bulgaria	Iliana Valkanova	Plovdiv
Bulgaria	MBAL Sveti Panteleimon	Plovdiv
Bulgaria	"Medical Center-Razgrad"OOD	Razgrad
Bulgaria	Medical Center Re Spiro OOD	Razgrad
Bulgaria	MBAL Sliven to VMA Sofia	Sliven
Bulgaria	Grigor Lalov	Smolyan
Bulgaria	SBALPFZ-Sofia district EOOD	Sofia
Bulgaria	Prevencia 2000 MCDMP OOD	Stara Zagora
Bulgaria	Medical Center "Research expert" OOD	Varna
Bulgaria	Medical Center "Tara" OOD	Veliko Tarnovo
Bulgaria	MC"Sv.Ivan Rilski"OOD	Vidin
Czechia	MUDr. Margit Hóracková	Šumperk
Czechia	MUDr. Jiri Dolecek	Žamberk
Czechia	MUDr. Michal Pasler	Žamberk
Czechia	MUDr. Alena Jelinkova	Bilina
Czechia	MUDr. Eva Krizova	Boskovice
Czechia	Ambulance pro nemoci plicni a TBC, s.r.o.	Brno
Czechia	Jana Jancíková	Brno
Czechia	MUDr Hana Vašínová	Brno
Czechia	MUDr. Ilona Binkova	Brno
Czechia	MUDr. Jana Slapnickova s.r.o.	Brno
Czechia	MUDr. Jaroslava Lovakova	Brno
Czechia	MUDr. Michal Svarc	Broumov
Czechia	Plicní Cáslav s.r.o.	Cáslav
Czechia	MUDr. Jan Faktor Medipont s.r.o.	Ceske Budejovice
Czechia	MUDr. Josef Hlavac Medipont s.r.o.	Ceske Budejovice
Czechia	MUDr. Martin Polasek	CeskyTesinKonakov
Czechia	MUDr. Renata Bilkova	Decín
Czechia	MUDr. Jiri Guthwirth	Dobrís
Czechia	MUDr. Martin Adamec Alergonet Group	Frydek-Mistek
Czechia	MUDr. Marie Buresova	Havlickuv Brod
Czechia	MUDr. Jana Psikalova	Holesov
Czechia	MUDr. Stanislava Bednarova	Holesov
Czechia	MUDr. Petr Šafránek	Horovice
Czechia	MUDr. Hana Lochmanova AXIMED s.r.o.	Hradec Kralove
Czechia	MUDr. Ales Bohac Plicni ambulance	Hranice
Czechia	MUDr. Lenka Fousova	Hustopece U Brna
Czechia	MUDr. Bohumil Kralicek	Jihlava
Czechia	MUDr. Jirina Knillova	Jihlava
Czechia	MUDr. Alexandra Woznicova	Jirkov
Czechia	MUDr. Michaela Baerova	Kosmonosy
Czechia	MUDr. Petr Kolman	Kyjov
Czechia	MUDr. Milanda Sipkova	Liberec
Czechia	Plucni Ambulance Louny s.r.o.	Louny
Czechia	MUDr. Ilona Pavlisova, s.r.o.	Miroslav
Czechia	MUDr. Michaela Baerova	Mlada Boreslav
Czechia	MUDr. Pavla Shihatova	Náchod
Czechia	MUDr. Dusan Velart	Novy Jicin
Czechia	MUDr. Sarka Hofrova	Novy Jicin
Czechia	MUDr. Sarka Klimesova	Nymburk
Czechia	MUDr. Ondrej Sobotik	Olomouc
Czechia	MUDr. RAdoslav Alexa	Orlová - Lutyne
Czechia	MUDr. Jana Balounova	Ostrava
Czechia	MUDr. Jana Kocianova	Ostrava
Czechia	MUDr. Milena Sramkova	Ostrava
Czechia	Plicní-ambulance Terezie Janásková, s.r.o	Ostrava, Belský Les
Czechia	MUDr. Miluse Zitkova	Pardubice
Czechia	MUDr. Tereza Dobesova Aximed s.r.o.	Pardubice
Czechia	MUDr. Jiri Zoula Aries Medici s.r.o.	Pelhrimov
Czechia	MUDr. Andrea Svabkova	Plzen
Czechia	MUDr. Jitka Smolova	Plzen
Czechia	MUDr. Petr Šafránek	Plzen
Czechia	MUDr. Petr Hartman	Plzen
Czechia	MUDr. Vladimir Makrlik	Plzen
Czechia	MUDr. Jana Janková Zátopková	Podebrady
Czechia	MUDr. Olga Krizova	Pohorelice
Czechia	MUDr. Fransitek Petrik	Praha
Czechia	MUDr. Ivana Jirmanova	Praha
Czechia	První plicní ambulance s.r.o.	Praha 1
Czechia	MUDr. Romana Davidova	Praha 4
Czechia	MUDr. Iva Stachova	Praha 5
Czechia	MUDr. Ivana Zatloukalova	Praha 5
Czechia	MUDr. Jana Jirouskova	Praha 6
Czechia	MUDr. Lenka Povysilova	Praha 6
Czechia	MUDr. Milada Typltová	Praha 6
Czechia	MUDr. Vera Pacovska	Praha 7
Czechia	MUDr. Vera Reichmanova	Praha 7
Czechia	MUDr. Bronislava Viest	Praha 9
Czechia	MUDr. Ivana Boucková	Praha 9
Czechia	MUDr. Romana Ivankova	Prostejov
Czechia	MUDr. Helena Ringlerova	Rokycany
Czechia	MUDr. Jaroslav Mares	Strakonice
Czechia	MUDr. Alena Kortusova	Usti nad Labem
Czechia	MUDr. Olga Martinkovicova	Usti nad Labem
Czechia	MUDr. Pavel Stach	Valasske Mezirici
Czechia	MUDr. Eva Sabova	Veselí nad Moravou
Czechia	MUDr. Pavel Matuska	Zabreh Na Morave
Czechia	MUDr. Alena Prochazkova	Zidlochovice
Hungary	Ecce Homo Orvosi Bt.	Balassagyarmat
Hungary	Dr. Major Katalin IZOPULM Kft.	Budapest
Hungary	Dr. Szabó Gyöngyi	Budapest
Hungary	Dr. Szilvia Vasas	Budapest
Hungary	Dr. Zoltan Gyula Bende	Budapest
Hungary	Emósi Bt.	Budapest
Hungary	FOKUSZ-PULMO Egeszsegügyi, Kutatasi, Oktatoi Tanacsado Bt	Budapest
Hungary	Fov.XIX.ker.Önk.Egészségügyi Int	Budapest
Hungary	Kineto-Med Bt.	Budapest
Hungary	Fenykepzeles KFT	Csitar
Hungary	Electro-Medic Bt.	Debrecen
Hungary	Rizikó '99	Debrecen
Hungary	Szent Pantaleon Hospital	Dunaújváros
Hungary	Pulmo Bt.	Edelény
Hungary	Dr. Gyetvainé Dr. Lanczki Éva	Eger
Hungary	Dr. Kontz Katalin	Gyöngyössolymos
Hungary	Dr. Szász Zoltán	Györ
Hungary	Györ Tüdögondozo	Györ
Hungary	Broncho-Vin BT.	Gyula
Hungary	Pulmoport Kft.	Gyula
Hungary	Rakvács-Mózes Bt.	Kaposvár
Hungary	Selye János Kórház, Rendelointézet, Tüdogondozó	Komarom
Hungary	Sz.-Sz.-B. MK és EOK. Mátészalka	Mátészalka
Hungary	Borsod-Abaúj-Zemplén Megyei Központ Kórház és Egyetemi Oktatókórház Semmelweis Tagkórház	Miskolc
Hungary	Dr. Bíró Margit	Monok
Hungary	Monor Szakrendelö Tüdögondozo	Monor
Hungary	Infer-Med Kft	Nagykozár
Hungary	Dr. Varga Ágnes	Pécs
Hungary	Ujpesti Szakorvosi Rendelöintezet	Pócsmegyer
Hungary	Dr. Anna Bartha	Siofok
Hungary	Dr. Breining és Társa Egészségügyi Szolgáltató Bt.	Sopron
Hungary	Dr. Radeczky Éva	Százhalombatta
Hungary	Dr. Bánvölgyi Aranka Milassinné	Szeged
Hungary	Dr. Geherne Dr. Huszar Hermina Eveline	Szombathely
Hungary	Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház	Vásárosnamény
Israel	ASSUTA Ashdod Ltd.	Ashdod
Israel	Barzilai Medical Center	Ashkelon
Israel	Clalit - Bat Yam	Bat Yam
Israel	Soroka Medical Center	Beer Sheva
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Carmel Medical Center	Haifa
Israel	Edith Wolfson Medical Center	Holon
Israel	Maccabi Healthcare	Holon
Israel	Research Fund of the Hadassah Medical Organization (R.A.)	Jerusalem
Israel	Shaarei Zedek Medical Center	Jerusalem
Israel	Clalit - Jerusalem East	Jerusalem East
Israel	Meir Medical Center Israel	Kfar Saba
Israel	Holy Family Hospital	Nazareth
Israel	Clalit Health Services	Petach Tikva
Israel	Rabin Medical Center (Beilinson Hospital)	Petach Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Health Corporation of the Ziv Medical Center (R.A.)	Safed
Israel	Clalit - Carmiel	Tel Aviv
Israel	Clalit - Nazareth	Tel Aviv
Israel	Clalit - Rishon	Tel Aviv
Israel	Sheba Medical Center	Tel-Hashomer / Ramat Gan
Israel	PORIYA Medical Center	Tiberias
Israel	Assaf Harofeh MC	Zrifin
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno klinikos	Kaunas
Lithuania	Enterprise Klaipeda University Hospital	Klaipeda
Lithuania	Klaipeda Hospital	Klaipeda
Lithuania	Public Enterprise Vilnius District Central Outpatient Clinic	Vilnius
Lithuania	Vilnius University Hospital Santaros klinikos	Vilnius
Poland	Specjalistyczy Gabinet Lekarski Urszula Swietlik Malesa	Biala Podlaska
Poland	ISPL Beata Kuklinska	Bialystok
Poland	Poradnia Chorób Pluc Samodzielny Publiczny Zaklad Opieki Zdrowotnej"Szpital Powiatowy"W Bochni	Bochnia
Poland	Indywidualna Praktyka Lekarska Aleksandra Burysz	Bydgoszcz
Poland	Specjalistyczna Praktyka Lekarska Choroby Pluc Agata Kalicka	Bydgoszcz
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Dr. n. med. Szymon Dworniczak	Chorzów
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Anna Góra-Florek	Ciecierzyn
Poland	ODM Gdynia	Gdynia
Poland	Specjalistyczna Praktyka Lekarska i USG	Jaslo
Poland	Specjalistyczny Gabinet Lekarski Juliusz Bokiej	Jelenia Góra
Poland	Indywidualna Specjalistyczna Praktyka Lekarska lek. Krzysztof Lis	Kielce
Poland	Niepubliczny Zaklad Opieki Specjalistycznej "Zdrowe Pluca"	Kielce
Poland	Lekarskie Wizyty Domowe Jaroslaw Zieba	Klomnice
Poland	Gabinet lekarski Renata Pejas-Dulewicz	Konskie
Poland	Gabinet lekarski Wojciech Machowiak	Koscian
Poland	Specjalistyczny Zespól Gruzlicy i chorób Pluc	Koszalin
Poland	Gabinet lekarski Thomasz Mysior	Kraków
Poland	Indywidualna Praktyka Lekarska Aleksander Kania	Kraków
Poland	Poradnia Chorób pluc	Kraków
Poland	Centrum Leczenia Chorób Pluc w Lodzi	Lódz
Poland	Przychodnia Specjalistyczna Snzoz Med Med. Sp.Z O.O	Lódz
Poland	Uniwersytecki Szpital Kliniczny Nr 1	Lódz
Poland	Alergopneuma sp. Z.o.o.	Lublin
Poland	Specjalistyczna Praktyka Lekarska Piotr Kaminski	Lublin
Poland	ISPL Lukasz Minarowski	Olmonty
Poland	Prywatny gabinet lakarski Izabela Pietowska-Lazuka	Parczew
Poland	Medycyna-diagnostyka Adam Nowinski	Piaseczno
Poland	Gabinet lekarski Edyta Kozinska	Plock
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Magdalena Kostrzewska	Poznan
Poland	MEDICAL-MED. Indywidualna Specjalistyczna Praktyka Lekarska Barbara Kuznar-Kaminska	Poznan
Poland	Poradnia Gruzlicy i Chorób Pluc SPZOZ Proszowice	Proszowice
Poland	Gabinet lekarski Roman Masarczyk	Pyskowice
Poland	Szpital Rejonowy im.dr Rostka-Oddzil Pulmonologiczny	Racibórz
Poland	Podkarpackie Centrum Chorób Pluc	Rzeszów
Poland	Gabinet lekarski Choroby pluc i oskrzeli Joanna Tesiorowska	Sieradz
Poland	NZOZ Poradnia Chorób Pluc i Alergologii	Slupsk
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Filipek	Sosnowiec
Poland	NZOZ Centrum Medyczne SBB	Tarnobrzeg
Poland	Viltis Medica Spejalistyczan Praktyla Lekarska lek.med. Agata Kot	Trzebnica
Poland	MSWiA	Warsaw
Poland	Gabinet lekarski Andrzej Jaworski	Warszawa
Poland	Gabinet lekarski Beata Zolnowska	Warszawa
Poland	Instytut Gruzlicy i Chorób Pluc	Warszawa
Poland	STANMED Gabinet Lekarski Robert Staniszewski	Warszawa
Poland	Wizyty Domowe Internisty B. Homola-Piekarska	Warszawa
Poland	Gabinet Internistyczny-Choroby pluc lek.med.M.Kraszewska	Wieruszów
Poland	Specjalistyczna Praktyka Lekarska dr n.med. Andrzej Obojski	Wroclaw
Poland	Specjalistyczny Szpital Chorób Pluc Odrodzenie im Klary Jelskiej	Zakopane
Romania	DaniPneumoMed SRL	Arad
Romania	Butacel F. Maria Danisia - Medic Specialist Pneumolog	Bacau
Romania	Manolache Cristina - Medic Specialist Pneumologie	Bistri?a
Romania	Dr. Bendas Magdalena	Boto?ani
Romania	Muresan Alina Pneumoconsult Srl	Brasov
Romania	Borcea Corina-Ioana Persoana Fizica Autorizata	Bucharest
Romania	Ispas Elena-Irina Medic Specialist Pneumolog	Bucure?ti
Romania	Dr Cosei Valentin-Caius Pfi	Bucuresti
Romania	Pneumo Clinic Care SRL	Constanta
Romania	Crm Pneumology Srl	Craiova
Romania	Nicolosu Med Srl	Craiova
Romania	Avencord SRL	Focsani
Romania	Miron V. Ramona - Medic Colaborator	Iasi
Romania	Howas Med Srl	Jud Constanta
Romania	Chis P Ana Florica - Medic Specialist Pneumologie	Jud. Cluj, Mun. Cluj-Napoca
Romania	Ciumarnean G Lorena Medic Specialist	Jud. Cluj, Mun. Cluj-Napoca
Romania	Cabinet Medical Individual Defta I. Doina-Elisabeta	Jud. Giurgiu , Mun. Giurgiu
Romania	Rarcolmed Srl	Milcovul
Romania	Vlad M. Elena - Medic Primar Pneumolog	Mun. Târgu Jiu
Romania	Medic Primar Pneumologie Stoleru Manuela	Piatra Neamt
Romania	Raissa Maria Medical Srl	Popesti Leordeni
Romania	Viosan-Resp S.R.L.	Râmnicu Vâlcea
Romania	PFI Chirea C. Monica Valentina	Ramnicu-Sarat
Romania	Jager Pneumo Services Srl	Sat Arini?
Romania	Sc Nexus Medical Srl	Sat Visan, Jud Iasi
Romania	Cabinet Medical Individual Dr. Butuc Lilia	Tg.Lapu?
Romania	Cabinet Medical Pneumologie Dr. Albu Claudia	Timisoara
Romania	CMI Dr. Mihailescu Constantin	Vanju Mare
Russian Federation	Treatment and consultation center	Angarsk
Russian Federation	Alexander Mariinsky regional clinical hospital	Astrakhan
Russian Federation	Volga district hospital	Astrakhan
Russian Federation	Barnaul city hospital Nr.5	Barnaul
Russian Federation	Departmental clinical hospital on the station Barnaul of OJSC "RZhD"	Barnaul
Russian Federation	Out-patient hospital "Harmony of health"	Belgorod
Russian Federation	Bryansk regional hospital No. 1	Bryansk
Russian Federation	Chekhov central district out-patient hospital	Checkov 2
Russian Federation	Chelyabinsk regional clinical hospital	Chelyabinsk
Russian Federation	Institution of public health City clinical hospital #11	Chelyabinsk
Russian Federation	LLC "AllergoStop", Center of asthma prophylactic and treatment of allergy and asthma	Chelyabinsk
Russian Federation	Regional Clinical Hospital Nr.3	Chelyabinsk
Russian Federation	Road clinical hospital at station Chelyabinsk RRR	Chelyabinsk
Russian Federation	Central city clinical hospital No. 1 of Oktyabrsky district	Ekaterinburg
Russian Federation	Central City Hospital Nr.7	Ekaterinburg
Russian Federation	Central clinical hospital Nr. 3	Ekaterinburg
Russian Federation	City clinical hospital No. 14	Ekaterinburg
Russian Federation	LLC Medical unity "Novaya Bolnitsa	Ekaterinburg
Russian Federation	Medical Association "Novaya Bolnitsa" Polyclinic	Ekaterinburg
Russian Federation	Sverdlovsk regional hospital Nr. 2	Ekaterinburg
Russian Federation	East and Siberian institute of medical and ecological studies	Irkutsk
Russian Federation	Irkutsk state clinical hospital Nr.1	Irkutsk
Russian Federation	Regional oncology dispensary	Irkutsk
Russian Federation	LLC Pulsar	Iskitim
Russian Federation	City clinical hospital No. 4	Ivanovo
Russian Federation	Kaluga regional clinical hospital	Kaluga
Russian Federation	City clinical hospital Nr. 16	Kazan
Russian Federation	LLC "City Clinical hospital #12"	Kazan
Russian Federation	Medical Association "Spasenie"	Kazan
Russian Federation	State autonomy institution of public health	Kazan
Russian Federation	Kemerovo regional clinical phthisiopulmonology medical center	Kemerovo
Russian Federation	Regional clinical hospital of emergency medical care named after M.A. Podgorbunsky	Kemerovo
Russian Federation	Kirov clinical and diagnostic centeron the basis of out-patient hospital Nr. 1	Kirov
Russian Federation	LLC "Doctor Lite"	Kirov
Russian Federation	Krai clinical hospital Nr. 1 named after prof. S.V. Ochapovskogo	Krasnodar
Russian Federation	Krai clinical hospital	Krasnoyarsk
Russian Federation	Krasnoyarsk inter-district clinical hospital Nr. 20 named after I.S. Berzon	Krasnoyarsk
Russian Federation	Kurgan out-patient hospital	Kurgan
Russian Federation	Kurgan regional clinical hospital	Kurgan
Russian Federation	Medassist-K	Kursk
Russian Federation	Out-patient hospital of regional budgetary institution of public health	Kursk
Russian Federation	Lipetsk city out-patient hospital Nr. 7	Lipetsk
Russian Federation	Republican clinical hospital of war and labor veterans	Makhachkala
Russian Federation	City out-patient hospital Nr. 134 of department of public health of Moscow	Moscow
Russian Federation	City out-patient hospital Nr. 22 of department of public health of Moscow, branch Nr. 2	Moscow
Russian Federation	City out-patient hospital Nr. 52 of department of public health of Moscow	Moscow
Russian Federation	Consultation and diagnostic center Nr. 6 of department of public health of Moscow	Moscow
Russian Federation	First Moscow State Medical University named after I. M. Sechenov	Moscow
Russian Federation	Institution of public health "City out-patient hospital #180 of department of public health of Moscow	Moscow
Russian Federation	Moscow Regional Research Clinical Institute named after M.F. Vladimirsky	Moscow
Russian Federation	Educational institution of higher education named after N.I. Pirogov of Ministry of health of Russia	Moskau
Russian Federation	Moscow scientific and clinical educational center for respiratory medicine	Moskau
Russian Federation	Nizhnevartovsk county hospital No.2	Nizhnevartovsk
Russian Federation	Nizhny Novgorod city clinical hospital named after N.A. Semashko	Nizhny Novgorod
Russian Federation	Nizhny Novgorod scientific and research institute of sanitary science and occupational pathology	Nizhny Novgorod
Russian Federation	Privolzhsky Research Medical University	Nizhny Novgorod
Russian Federation	Novokuznetsk city clinical hospital Nr. 29	Novokuznetsk
Russian Federation	Azbuka zdoroviya	Novosibirsk
Russian Federation	City clinical hospital No. 2	Novosibirsk
Russian Federation	Road clinical hospital on station Novosibirsk-Main of OJSC "RZhD"	Novosibirsk
Russian Federation	Scientific and research institute of physiology and fundamental medicine	Novosibirsk
Russian Federation	Zdorovaya Semiya	Novosibirsk
Russian Federation	City clinical out-patient hospital No. 1	Novovsibirsk
Russian Federation	City out-patient hospital No. 2	Omsk
Russian Federation	Clinical medical sanitary station Nr. 7	Omsk
Russian Federation	Multifunctional center of modern medicine "Evromed"	Omsk
Russian Federation	ZAO "Multifunctional center of modern medicine "Evromed"	Omsk
Russian Federation	City hospital named after S. P. Botkin	Orel
Russian Federation	Orenburg regional clinical hospital No. 2	Orenburg
Russian Federation	Clinical hospital No. 6 named after G.A. Zakhariyn	Penza
Russian Federation	Penza regional clinical hospital named after N.N. Burdenko	Penza
Russian Federation	"City out-patient hospital #7" on the basis of out-patient hospital #2	Perm
Russian Federation	City clinical out-patient hospital #2	Perm
Russian Federation	City clinical out-patient hospital No. 4	Perm
Russian Federation	City clinical out-patient hospital of Perm	Perm
Russian Federation	Perm clinical center of federal medical and biological agency "Medical sanitary station #140" on the basis of out-patient hospital #2	Perm
Russian Federation	Perm regional clinical hospital	Perm
Russian Federation	Hospital of Karelia republic named after V.A.Baranov	Petrozavodsk
Russian Federation	1586 military clinical hospital of Ministri of Public Defense	Podolsk
Russian Federation	Treatment and prophylactic institution of union health resort "Rodnik"	Pyatigorsk
Russian Federation	City clinical hospital No. 20 of Rostov-on-Don"	Rostov-on-Don
Russian Federation	Clinical and diagnostic center "Zdorovie" of Rostov-on-Don	Rostov-on-Don
Russian Federation	Rostov regional clinical hospital	Rostov-on-Don
Russian Federation	Regional clinical cardiology dispensary	Ryazan
Russian Federation	Regional clinical hospital	Ryazan
Russian Federation	Aleksandrovskaya City Hospitel	Saint Petersburg
Russian Federation	First Saint-Petersburg state medical university named after acad. I.P.Pavlov	Saint-Petersburg
Russian Federation	LLC "Medical center XXI century" Bryanseva 13"	Saint-Petersburg
Russian Federation	ZAO "Medi"	Saint-Petersburg
Russian Federation	City clinical hospital Nr 4 of Samara	Samara
Russian Federation	Samara city clinical out-patient hospital No.15	Samara
Russian Federation	Samara city hospital Nr. 13 of Zheleznodorozhny district	Samara
Russian Federation	Samara city out-patient hospital No.1	Samara
Russian Federation	Samara medical and sanitary unit Nr. 5 of the Kirovsky district	Samara
Russian Federation	City Consultative and Diagnostic Centre Nr. 1	Sankt Petersburg
Russian Federation	National Mordovia research state university named after N.P. Ogarev	Saransk
Russian Federation	Saratov city clinical hospital No. 8	Saratov
Russian Federation	Saratov city out-patient hospital Nr. 10	Saratov
Russian Federation	Saratov city out-patient hospital Nr. 9	Saratov
Russian Federation	Simferopol city clinical hospital Nr. 7	Simferopol
Russian Federation	Simferopol clinical hospital	Simferopol
Russian Federation	Clinical hospital No. 1	Smolensk
Russian Federation	Out-patient hospital #5	Smolensk
Russian Federation	Institute of Medical Trials	St. Petersburg
Russian Federation	Stavropol krai clinical hospital	Stavropol
Russian Federation	Tambov regional clinical hospital named after V.D. Babenko	Tambov
Russian Federation	Tolyatti city hospital Nr. 5	Tolyatti
Russian Federation	Federal state budgetary institution of SibFNKC FMBA of Russia	Tomsk
Russian Federation	Out-patient hospital No. 1	Tomsk
Russian Federation	Tomsk Regional clinical hospital	Tomsk
Russian Federation	Treatment and diagnostic center	Tomsk
Russian Federation	City hospital Nr. 9	Tula
Russian Federation	Regional Clinical Hospital	Tver
Russian Federation	Regional hospital No. 19 Out-patient hospital	Tyumen
Russian Federation	City clinical hospital Nr. 21	Ufa
Russian Federation	Republican clinical hospital named after G.G. Kuvatov	Ufa
Russian Federation	Vladimir Regional clinical hospital	Vladimir
Russian Federation	Non-state institution of public health Divisional clinical hospital on station Volgograd-1 of OJSC "RZhD"	Volgograd
Russian Federation	Volgograd regional clinical hospital Nr. 1	Volgograd
Russian Federation	Institution of public health of Voronezh region "Voronezh regional clinical consultation and diagnostic center"	Voronezh
Russian Federation	LLC medical center "Diagnostic plus"	Voronezh
Russian Federation	Institution of public health of Yaroslavl region Regional clinical hospital	Yaroslavl
Slovenia	Prim. mag. Šegota Nikša, dr.med., specialisticna zdravniška dejavnost, s.p.	Škofja vas
Slovenia	Internisticna ambulanta za pljucne in alergijske bolezni Karmen Kramer Vršcaj	Celje
Slovenia	Pulmološka ambulanta dr. Snežana Ulcar Kostic s.p.	Kamnik
Slovenia	MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o.	Kocevje
Slovenia	VELOG, Zdravstveni center, d.o.o.	Kranj
Slovenia	Zdravstvene storitve in svetovanje, Tjaša Šubic s.p.	Kranj
Slovenia	Verboten Kopriva Renata - Ordinacija Interne Medicine	Litija
Slovenia	Arjana Macek d.o.o	Ljubljana
Slovenia	Kambic-Kafol d.o.o.	Ljubljana
Slovenia	Medvital Katarina Vukelic s.p.	Ljubljana
Slovenia	Alveola, internisticni ambulantni diagnosticni center d.o.o.	Maribor
Slovenia	CIIM PLUS, center za interno in interventno medicino, d.o.o.	Maribor
Slovenia	INTERNIST MB - specialisticna ambulantna dejavnost, Marko Bombek s.p.	Maribor
Slovenia	Zdravstveno svetovanje in storitve, Krstic Zoran, s.p.	Maribor
Slovenia	Mag. Anton Lopert, dr.med. - Zasebna internisticna ambulanta	Murska Sobota
Slovenia	Zasebna ambulanta za pljucne bolezni, mag. Alojz Horvat, dr. med.	Murska Sobota
Slovenia	Dr. Ana Novakovic	Velenje
Slovenia	Dr. med. Tomaz Smonkar	Velenje
Slovenia	Dr. Mikro Lekic	Velenje
Switzerland	Gruppenpraxis Basel	Basel
Switzerland	Gruppenpraxis Frick	Frick
Switzerland	Gruppenpraxis Emmenbrücke	Geuensee
Switzerland	Berner Reha Zentrum Medizin Pneumologie	Heiligenschwendi
Switzerland	Gruppenpraxis Luzern	Luzern
Switzerland	Spital Linth	Utznach
Switzerland	Zürcher RehaZentrum Wald	Wald
Ukraine	Dnipropetrovsk 6 City clinical Hospital	Dnipropetrovsk
Ukraine	Regional centre of Phtysiology and Pulmonology	Ivano-Frankivsk
Ukraine	City Clinical Hospital Nr. 13	Kharkiv
Ukraine	National Institute of Phthisiology and Pulmonology named F. G. Yanovsky National Academy of Medical Sciences of Ukraine	Kyiv
Ukraine	Volyn Regional Clinical Hospital	Lutsk
Ukraine	Lviv Regional Phthisiopneumological Clinical Treatment and Diagnostic Center	Lviv
Ukraine	Vinnytsia City Clinical Hospital Nr. 1	Vinnitsa

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Hungary,  Israel,  Lithuania,  Poland,  Romania,  Russian Federation,  Slovenia,  Switzerland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2	Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.	At Visit 2 (6 weeks after baseline visit 1)
Secondary	Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2	The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1.	At baseline visit 1 and 6 weeks thereafter at visit 2
Secondary	Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)	PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).	At visit 1
Secondary	Physician's Global Evaluation (PGE) Score at Visit 2	PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).	At visit 2 (6 weeks after baseline visit 1)
Secondary	Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2	Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.	At visit 2
Secondary	Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2	Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported	At visit 2
Secondary	Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2	Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.	At visit 2
Secondary	Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2	Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.	At visit 2

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