AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructiveNCT03663569

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 388 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Spiolto® Respimat®
How many people
4,819 participants
Where
388 sitesin 11 countries
Study dates
15 Aug 2018to 4 Oct 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Around 4500 COPD patients from approximately 11 countries will be collected, with a signed informed consent will be maintained in the ISF at the investigational site irrespective of whether they have been treated or not.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

388 sites in 11 countries.

388 sites in 11 countries

Russia122 sites

  • Treatment and consultation center

    Angarsk, 665831

  • Volga district hospital

    Astrakhan, 414018

  • Alexander Mariinsky regional clinical hospital

    Astrakhan, 414056

  • Departmental clinical hospital on the station Barnaul of OJSC "RZhD"

    Barnaul, 656000

  • Barnaul city hospital Nr.5

    Barnaul, 656045

  • Out-patient hospital "Harmony of health"

    Belgorod, 308015

  • Bryansk regional hospital No. 1

    Bryansk, 214028

  • Chekhov central district out-patient hospital

    Checkov 2, 142302

  • Chelyabinsk regional clinical hospital

    Chelyabinsk, 454076

  • Road clinical hospital at station Chelyabinsk RRR

    Chelyabinsk, 454091

  • LLC "AllergoStop", Center of asthma prophylactic and treatment of allergy and asthma

    Chelyabinsk, 454106

  • Regional Clinical Hospital Nr.3

    Chelyabinsk, 454106

  • Institution of public health City clinical hospital #11

    Chelyabinsk, 454219

  • Regional oncology dispensary

    Irkutsk, 644032

  • Irkutsk state clinical hospital Nr.1

    Irkutsk, 664046

  • East and Siberian institute of medical and ecological studies

    Irkutsk, 665827

  • LLC Pulsar

    Iskitim, 633000

  • City clinical hospital No. 4

    Ivanovo, 153005

  • Kaluga regional clinical hospital

    Kaluga, 248007

  • LLC "City Clinical hospital #12"

    Kazan', 420036

  • Medical Association "Spasenie"

    Kazan', 420059

  • City clinical hospital Nr. 16

    Kazan', 420064

  • State autonomy institution of public health

    Kazan', 420064

  • Kemerovo regional clinical phthisiopulmonology medical center

    Kemerovo, 650036

  • Regional clinical hospital of emergency medical care named after M.A. Podgorbunsky

    Kemerovo, 650993

  • LLC "Doctor Lite"

    Kirov, 610000

  • Kirov clinical and diagnostic centeron the basis of out-patient hospital Nr. 1

    Kirov, 610050

  • Krai clinical hospital Nr. 1 named after prof. S.V. Ochapovskogo

    Krasnodar, 350086

  • Krai clinical hospital

    Krasnoyarsk, 660022

  • Krasnoyarsk inter-district clinical hospital Nr. 20 named after I.S. Berzon

    Krasnoyarsk, 661123

  • Kurgan out-patient hospital

    Kurgan, 640000

  • Kurgan regional clinical hospital

    Kurgan, 640000

  • Out-patient hospital of regional budgetary institution of public health

    Kursk, 305004

  • Medassist-K

    Kursk, 306900

  • Lipetsk city out-patient hospital Nr. 7

    Lipetsk, 398046

  • Republican clinical hospital of war and labor veterans

    Makhachkala, 367000

  • Educational institution of higher education named after N.I. Pirogov of Ministry of health of Russia

    Moscow, 105077

  • Moscow scientific and clinical educational center for respiratory medicine

    Moscow, 105077

  • City out-patient hospital Nr. 22 of department of public health of Moscow, branch Nr. 2

    Moscow, 117449

  • City out-patient hospital Nr. 134 of department of public health of Moscow

    Moscow, 117463

  • City out-patient hospital Nr. 52 of department of public health of Moscow

    Moscow, 117546

  • First Moscow State Medical University named after I. M. Sechenov

    Moscow, 119991

  • Institution of public health "City out-patient hospital #180 of department of public health of Moscow

    Moscow, 125222

  • Consultation and diagnostic center Nr. 6 of department of public health of Moscow

    Moscow, 127540

  • Moscow Regional Research Clinical Institute named after M.F. Vladimirsky

    Moscow, 129110

  • Nizhnevartovsk county hospital No.2

    Nizhnevartovsk, 628624

  • Nizhny Novgorod scientific and research institute of sanitary science and occupational pathology

    Nizhny Novgorod, 603005

  • Privolzhsky Research Medical University

    Nizhny Novgorod, 603005

  • Nizhny Novgorod city clinical hospital named after N.A. Semashko

    Nizhny Novgorod, 603093

  • Novokuznetsk city clinical hospital Nr. 29

    Novokuznetsk, 654038

  • Azbuka zdoroviya

    Novosibirsk, 360000

  • Road clinical hospital on station Novosibirsk-Main of OJSC "RZhD"

    Novosibirsk, 360003

  • City clinical hospital No. 2

    Novosibirsk, 360051

  • Zdorovaya Semiya

    Novosibirsk, 630099

  • Scientific and research institute of physiology and fundamental medicine

    Novosibirsk, 630117

  • City clinical out-patient hospital No. 1

    Novovsibirsk, 630099

  • Clinical medical sanitary station Nr. 7

    Omsk, 644000

  • City out-patient hospital No. 2

    Omsk, 644009

  • Multifunctional center of modern medicine "Evromed"

    Omsk, 644024

  • ZAO "Multifunctional center of modern medicine "Evromed"

    Omsk, 644033

  • Orenburg regional clinical hospital No. 2

    Orenburg, 460000

  • City hospital named after S. P. Botkin

    Oryol, 302000

  • Penza regional clinical hospital named after N.N. Burdenko

    Penza, 440026

  • Clinical hospital No. 6 named after G.A. Zakhariyn

    Penza, 440071

  • City clinical out-patient hospital of Perm

    Perm, 614000

  • Perm clinical center of federal medical and biological agency "Medical sanitary station #140" on the basis of out-patient hospital #2

    Perm, 614038

  • City clinical out-patient hospital #2

    Perm, 614066

  • "City out-patient hospital #7" on the basis of out-patient hospital #2

    Perm, 614070

  • City clinical out-patient hospital No. 4

    Perm, 614097

  • Perm regional clinical hospital

    Perm, 614990

  • Hospital of Karelia republic named after V.A.Baranov

    Petrozavodsk, 185007

  • 1586 military clinical hospital of Ministri of Public Defense

    Podolsk, 142110

  • Treatment and prophylactic institution of union health resort "Rodnik"

    Pyatigorsk, 357500

  • Clinical and diagnostic center "Zdorovie" of Rostov-on-Don

    Rostov-on-Don, 344011

  • Rostov regional clinical hospital

    Rostov-on-Don, 344015

  • City clinical hospital No. 20 of Rostov-on-Don"

    Rostov-on-Don, 344091

  • Regional clinical cardiology dispensary

    Ryazan, 390026

  • Regional clinical hospital

    Ryazan, 390039

  • ZAO "Medi"

    Saint Petersburg, 191025

  • LLC "Medical center XXI century" Bryanseva 13"

    Saint Petersburg, 191952

  • Aleksandrovskaya City Hospitel

    Saint Petersburg, 193312

  • City Consultative and Diagnostic Centre Nr. 1

    Saint Petersburg, 194354

  • Institute of Medical Trials

    Saint Petersburg, 196084

  • First Saint-Petersburg state medical university named after acad. I.P.Pavlov

    Saint Petersburg, 197022

  • Samara city out-patient hospital No.1

    Samara, 443000

  • Samara medical and sanitary unit Nr. 5 of the Kirovsky district

    Samara, 443051

  • City clinical hospital Nr 4 of Samara

    Samara, 443056

  • Samara city hospital Nr. 13 of Zheleznodorozhny district

    Samara, 443069

  • Samara city clinical out-patient hospital No.15

    Samara, 443111

  • National Mordovia research state university named after N.P. Ogarev

    Saransk, 430005

  • Saratov city out-patient hospital Nr. 9

    Saratov, 410033

  • Saratov city clinical hospital No. 8

    Saratov, 410052

  • Saratov city out-patient hospital Nr. 10

    Saratov, 410053

  • Simferopol city clinical hospital Nr. 7

    Simferopol, 295024

  • Simferopol clinical hospital

    Simferopol, 950000

  • Out-patient hospital #5

    Smolensk, 214000

  • Clinical hospital No. 1

    Smolensk, 214012

  • Stavropol krai clinical hospital

    Stavropol, 355030

  • Tambov regional clinical hospital named after V.D. Babenko

    Tambov, 392000

  • Tolyatti city hospital Nr. 5

    Tolyatti, 445039

  • Treatment and diagnostic center

    Tomsk, 634012

  • Out-patient hospital No. 1

    Tomsk, 634050

  • Tomsk Regional clinical hospital

    Tomsk, 634063

  • Federal state budgetary institution of SibFNKC FMBA of Russia

    Tomsk, 636037

  • City hospital Nr. 9

    Tula, 300002

  • Regional Clinical Hospital

    Tver', 170036

  • Regional hospital No. 19 Out-patient hospital

    Tyumen, 625017

  • City clinical hospital Nr. 21

    Ufa, 450071

  • Republican clinical hospital named after G.G. Kuvatov

    Ufa, 450071

  • Vladimir Regional clinical hospital

    Vladimir, 600023

  • Volgograd regional clinical hospital Nr. 1

    Volgograd, 400081

  • Non-state institution of public health Divisional clinical hospital on station Volgograd-1 of OJSC "RZhD"

    Volgograd, 400120

  • Institution of public health of Voronezh region "Voronezh regional clinical consultation and diagnostic center"

    Voronezh, 394018

  • LLC medical center "Diagnostic plus"

    Voronezh, 394026

  • Institution of public health of Yaroslavl region Regional clinical hospital

    Yaroslavl, 150062

  • LLC Medical unity "Novaya Bolnitsa

    Yekaterinburg, 320109

  • Sverdlovsk regional hospital Nr. 2

    Yekaterinburg, 620000

  • Central city clinical hospital No. 1 of Oktyabrsky district

    Yekaterinburg, 620026

  • City clinical hospital No. 14

    Yekaterinburg, 620039

  • Central clinical hospital Nr. 3

    Yekaterinburg, 620067

  • Medical Association "Novaya Bolnitsa" Polyclinic

    Yekaterinburg, 620109

  • Central City Hospital Nr.7

    Yekaterinburg, 620137

Other trials in Russia

Czechia77 sites

  • MUDr. Alena Jelinkova

    Bílina, 418 01

  • MUDr. Eva Krizova

    Boskovice, 68001

  • Ambulance pro nemoci plicni a TBC, s.r.o.

    Brno, 60200

  • Jana Jančíková

    Brno, 60200

  • MUDr Hana Vašínová

    Brno, 60200

  • MUDr. Ilona Binkova

    Brno, 60200

  • MUDr. Jana Slapnickova s.r.o.

    Brno, 60200

  • MUDr. Jaroslava Lovakova

    Brno, 60200

  • MUDr. Michal Svarc

    Broumov, 55001

  • Plicní Čáslav s.r.o.

    Čáslav, 28601

  • MUDr. Jan Faktor Medipont s.r.o.

    České Budějovice, 370 01

  • MUDr. Josef Hlavac Medipont s.r.o.

    České Budějovice, 370 01

  • MUDr. Martin Polasek

    CeskyTesinKonakov, 735 62

  • MUDr. Renata Bilkova

    Děčín, 40502

  • MUDr. Jiri Guthwirth

    Dobřís, 26301

  • MUDr. Martin Adamec Alergonet Group

    Frýdek-Místek, 738 01

  • MUDr. Marie Buresova

    Havlíčkův Brod, 580 01

  • MUDr. Jana Psikalova

    Holešov, 76901

  • MUDr. Stanislava Bednarova

    Holešov, 76901

  • MUDr. Petr Šafránek

    Hořovice, 268 31

  • MUDr. Hana Lochmanova AXIMED s.r.o.

    Hradec Králové, 500 02

  • MUDr. Ales Bohac Plicni ambulance

    Hranice, 753 22

  • MUDr. Lenka Fousova

    Hustopece U Brna, 693 01

  • MUDr. Bohumil Kralicek

    Jihlava, 586 01

  • MUDr. Jirina Knillova

    Jihlava, 586 01

  • MUDr. Alexandra Woznicova

    Jirkov, 431 11

  • MUDr. Michaela Baerova

    Kosmonosy, 293 06

  • MUDr. Petr Kolman

    Kyjov, 69701

  • MUDr. Milanda Sipkova

    Liberec, 460 05

  • Plucni Ambulance Louny s.r.o.

    Louny, 44001

  • MUDr. Ilona Pavlisova, s.r.o.

    Miroslav, 67172

  • MUDr. Michaela Baerova

    Mlada Boreslav, 29301

  • MUDr. Pavla Shihatova

    Náchod, 547 01

  • MUDr. Dusan Velart

    Nový Jičín, 741 01

  • MUDr. Sarka Hofrova

    Nový Jičín, 741 01

  • MUDr. Sarka Klimesova

    Nymburk, 288 01

  • MUDr. Ondrej Sobotik

    Olomouc, 779 00

  • MUDr. RAdoslav Alexa

    Orlová - Lutyně, 735 14

  • MUDr. Milena Sramkova

    Ostrava, 700 30

  • MUDr. Jana Balounova

    Ostrava, 70868

  • MUDr. Jana Kocianova

    Ostrava, 70868

  • Plicní-ambulance Terezie Janásková, s.r.o

    Ostrava, Bělský Les, 700 30

  • MUDr. Tereza Dobesova Aximed s.r.o.

    Pardubice, 530 02

  • MUDr. Miluse Zitkova

    Pardubice, 530 09

  • MUDr. Jiri Zoula Aries Medici s.r.o.

    Pelhřimov, 396 01

  • MUDr. Petr Hartman

    Pilsen, 301 00

  • MUDr. Jitka Smolova

    Pilsen, 30100

  • MUDr. Vladimir Makrlik

    Pilsen, 30100

  • MUDr. Petr Šafránek

    Pilsen, 312 00

  • MUDr. Andrea Svabkova

    Pilsen, 323 00

  • MUDr. Jana Janková Zátopková

    Poděbrady, 290 01

  • MUDr. Olga Krizova

    Pohořelice, 691 23

  • První plicní ambulance s.r.o.

    Prague, 11000

  • MUDr. Fransitek Petrik

    Prague, 120 00

  • MUDr. Romana Davidova

    Prague, 14800

  • MUDr. Iva Stachova

    Prague, 150 00

  • MUDr. Ivana Zatloukalova

    Prague, 150 00

  • MUDr. Milada Typltová

    Prague, 161 00

  • MUDr. Ivana Jirmanova

    Prague, 16200

  • MUDr. Jana Jirouskova

    Prague, 169 00

  • MUDr. Lenka Povysilova

    Prague, 169 00

  • MUDr. Vera Reichmanova

    Prague, 170 00

  • MUDr. Vera Pacovska

    Prague, 17000

  • MUDr. Bronislava Viest

    Prague, 19061

  • MUDr. Ivana Boučková

    Prague, 19800

  • MUDr. Romana Ivankova

    Prostějov, 79601

  • MUDr. Helena Ringlerova

    Rokycany, 33701

  • MUDr. Jaroslav Mares

    Strakonice, 386 01

  • MUDr. Margit Hóracková

    Šumperk, 78701

  • MUDr. Alena Kortusova

    Ústí nad Labem, 400 01

  • MUDr. Olga Martinkovicova

    Ústí nad Labem, 419 01

  • MUDr. Pavel Stach

    Valašské Meziříčí, 75701

  • MUDr. Eva Sabova

    Veselí nad Moravou, 69801

  • MUDr. Pavel Matuska

    Zábřeh, 78901

  • MUDr. Jiri Dolecek

    Žamberk, 564 01

  • MUDr. Michal Pasler

    Žamberk, 56401

  • MUDr. Alena Prochazkova

    Židlochovice, 667 01

Other trials in Czechia

Poland48 sites

  • Specjalistyczy Gabinet Lekarski Urszula Świetlik Malesa

    Biała Podlaska, 21-500

  • ISPL Beata Kuklińska

    Bialystok, 15-003

  • Poradnia Chorób Płuc Samodzielny Publiczny Zakład Opieki Zdrowotnej"Szpital Powiatowy"W Bochni

    Bochnia, 32-700

  • Indywidualna Praktyka Lekarska Aleksandra Burysz

    Bydgoszcz, 85-324

  • Specjalistyczna Praktyka Lekarska Choroby Płuc Agata Kalicka

    Bydgoszcz, 85-915

  • Indywidualna Specjalistyczna Praktyka Lekarska Dr. n. med. Szymon Dworniczak

    Chorzów, 41-500

  • Indywidualna Specjalistyczna Praktyka Lekarska Anna Góra-Florek

    Ciecierzyn, 21-003

  • ODM Gdynia

    Gdynia, 81-363

  • Gabinet lekarski Renata Pejas-Dulewicz

    Gmina Końskie, 26-200

  • Specjalistyczna Praktyka Lekarska i USG

    Jasło, 38-200

  • Specjalistyczny Gabinet Lekarski Juliusz Bokiej

    Jelenia Góra, 58-500

  • Niepubliczny Zakład Opieki Specjalistycznej "Zdrowe Płuca"

    Kielce, 25-528

  • Indywidualna Specjalistyczna Praktyka Lekarska lek. Krzysztof Lis

    Kielce, 25-751

  • Lekarskie Wizyty Domowe Jarosław Zięba

    Kłomnice, 42-270

  • Gabinet lekarski Wojciech Machowiak

    Kościan, 64000

  • Specjalistyczny Zespół Gruźlicy i chorób Płuc

    Koszalin, 75-252

  • Poradnia Chorób płuc

    Krakow, 30-901

  • Indywidualna Praktyka Lekarska Aleksander Kania

    Krakow, 31-443

  • Gabinet lekarski Thomasz Mysior

    Krakow, 31-619

  • Uniwersytecki Szpital Kliniczny Nr 1

    Lodz, 90-153

  • Centrum Leczenia Chorób Płuc w Łodzi

    Lodz, 91-520

  • Przychodnia Specjalistyczna Snzoz Med Med. Sp.Z O.O

    Lodz, 93-219

  • Specjalistyczna Praktyka Lekarska Piotr Kamiński

    Lublin, 20-086

  • Alergopneuma sp. Z.o.o.

    Lublin, 20-089

  • ISPL Łukasz Minarowski

    Olmonty, 15-603

  • Prywatny gabinet lakarski Izabela Piętowska-Łazuka

    Parczew, 21-200

  • Medycyna-diagnostyka Adam Nowiński

    Piaseczno, 05-500

  • Gabinet lekarski Edyta Kozińska

    Płock, 09-408

  • MEDICAL-MED. Indywidualna Specjalistyczna Praktyka Lekarska Barbara Kuźnar-Kamińska

    Poznan, 60-313

  • Indywidualna Specjalistyczna Praktyka Lekarska Magdalena Kostrzewska

    Poznan, 60-750

  • Poradnia Gruźlicy i Chorób Płuc SPZOZ Proszowice

    Proszowice, 32-100

  • Gabinet lekarski Roman Masarczyk

    Pyskowice, 44-120

  • Szpital Rejonowy im.dr Rostka-Oddził Pulmonologiczny

    Racibórz, 47-400

  • Podkarpackie Centrum Chorób Płuc

    Rzeszów, 35-241

  • Gabinet lekarski Choroby płuc i oskrzeli Joanna Tęsiorowska

    Sieradz, 98-200

  • NZOZ Poradnia Chorób Płuc i Alergologii

    Słupsk, 76-200

  • Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Filipek

    Sosnowiec, 41-200

  • NZOZ Centrum Medyczne SBB

    Tarnobrzeg, 39-400

  • Viltis Medica Spejalistyczan Praktyla Lekarska lek.med. Agata Kot

    Trzebnica, 55-100

  • STANMED Gabinet Lekarski Robert Staniszewski

    Warsaw, 00-201

  • Instytut Gruźlicy i Chorób Płuc

    Warsaw, 01-164

  • Gabinet lekarski Beata Żołnowska

    Warsaw, 01-631

  • MSWiA

    Warsaw, 02-507

  • Wizyty Domowe Internisty B. Homola-Piekarska

    Warsaw, 03-984

  • Gabinet lekarski Andrzej Jaworski

    Warsaw, 04-907

  • Gabinet Internistyczny-Choroby płuc lek.med.M.Kraszewska

    Wieruszów, 98-400

  • Specjalistyczna Praktyka Lekarska dr n.med. Andrzej Obojski

    Wroclaw, 51-664

  • Specjalistyczny Szpital Chorób Płuc Odrodzenie im Klary Jelskiej

    Zakopane, 34-500

Other trials in Poland

Hungary35 sites

  • Ecce Homo Orvosi Bt.

    Balassagyarmat, 2660

  • Dr. Major Katalin IZOPULM Kft.

    Budapest, 1011

  • FOKUSZ-PULMO Egeszsegügyi, Kutatasi, Oktatoi Tanacsado Bt

    Budapest, 1025

  • Kineto-Med Bt.

    Budapest, 1032

  • Dr. Szabó Gyöngyi

    Budapest, 1119

  • Dr. Szilvia Vasas

    Budapest, 1122

  • Emósi Bt.

    Budapest, 1165

  • Főv.XIX.ker.Önk.Egészségügyi Int

    Budapest, 1191

  • Dr. Zoltan Gyula Bende

    Budapest, 1220

  • Fenykepzeles KFT

    Csitár, 2673

  • Electro-Medic Bt.

    Debrecen, 4028

  • Rizikó '99

    Debrecen, 4028

  • Szent Pantaleon Hospital

    Dunaújváros, 2400

  • Pulmo Bt.

    Edelény, 3780

  • Dr. Gyetvainé Dr. Lanczki Éva

    Eger, 3300

  • Dr. Kontz Katalin

    Gyöngyössolymos, 3231

  • Dr. Szász Zoltán

    Győr, 9021

  • Györ Tüdögondozo

    Győr, 9023

  • Broncho-Vin BT.

    Gyula, 5700

  • Pulmoport Kft.

    Gyula, 5700

  • Rakvács-Mózes Bt.

    Kaposvár, 7400

  • Selye János Kórház, Rendelőintézet, Tüdőgondozó

    Komárom, 2900

  • Sz.-Sz.-B. MK és EOK. Mátészalka

    Mátészalka, 4700

  • Borsod-Abaúj-Zemplén Megyei Központ Kórház és Egyetemi Oktatókórház Semmelweis Tagkórház

    Miskolc, 3529

  • Dr. Bíró Margit

    Monok, 3905

  • Monor Szakrendelö Tüdögondozo

    Monor, 2200

  • Infer-Med Kft

    Nagykozár, 7741

  • Dr. Varga Ágnes

    Pécs, 7625

  • Ujpesti Szakorvosi Rendelöintezet

    Pócsmegyer, 2017

  • Dr. Anna Bartha

    Siófok, 8600

  • Dr. Breining és Társa Egészségügyi Szolgáltató Bt.

    Sopron, 9400

  • Dr. Radeczky Éva

    Százhalombatta, 2440

  • Dr. Bánvölgyi Aranka Milassinné

    Szeged, 6728

  • Dr. Geherne Dr. Huszar Hermina Eveline

    Szombathely, 9700

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

    Vásárosnamény, 4800

Other trials in Hungary

Romania28 sites

  • DaniPneumoMed SRL

    Arad, 315200

  • Butacel F. Maria Danisia - Medic Specialist Pneumolog

    Bacau, 600148

  • Manolache Cristina - Medic Specialist Pneumologie

    Bistrița, 420080

  • Dr. Bendas Magdalena

    Botoșani, 710336

  • Muresan Alina Pneumoconsult Srl

    Brasov, 500295

  • Dr Cosei Valentin-Caius Pfi

    Bucharest, 31746

  • Borcea Corina-Ioana Persoana Fizica Autorizata

    Bucharest, 61191

  • Ispas Elena-Irina Medic Specialist Pneumolog

    Bucharest, 61593

  • Pneumo Clinic Care SRL

    Constanța, 900621

  • Crm Pneumology Srl

    Craiova, 200501

  • Nicolosu Med Srl

    Craiova, 200677

  • Avencord SRL

    Focşani, 620003

  • Miron V. Ramona - Medic Colaborator

    Iași, 700233

  • Howas Med Srl

    Jud Constanta, 38079525

  • Ciumarnean G Lorena Medic Specialist

    Jud. Cluj, Mun. Cluj-Napoca, 400414

  • Chis P Ana Florica - Medic Specialist Pneumologie

    Jud. Cluj, Mun. Cluj-Napoca, 400426

  • Cabinet Medical Individual Defta I. Doina-Elisabeta

    Jud. Giurgiu , Mun. Giurgiu, 80121

  • Rarcolmed Srl

    Milcovul, 30167

  • Vlad M. Elena - Medic Primar Pneumolog

    Mun. Târgu Jiu, 210164

  • Medic Primar Pneumologie Stoleru Manuela

    Piatra Neamţ, 610255

  • Raissa Maria Medical Srl

    Popeşti-Leordeni, 77160

  • PFI Chirea C. Monica Valentina

    Râmnicu Sărat, 5273

  • Viosan-Resp S.R.L.

    Râmnicu Vâlcea, 167473

  • Jager Pneumo Services Srl

    Sat Ariniș, 437010

  • Sc Nexus Medical Srl

    Sat Visan, Jud Iasi, 700285

  • Cabinet Medical Individual Dr. Butuc Lilia

    Tg.Lăpuș, 435600

  • Cabinet Medical Pneumologie Dr. Albu Claudia

    Timișoara, 300587

  • CMI Dr. Mihailescu Constantin

    Vânju-Mare, 225400

Other trials in Romania

Israel23 sites

  • ASSUTA Ashdod Ltd.

    Ashdod, 77000

  • Barzilai Medical Center

    Ashkelon, 78306

  • Clalit - Bat Yam

    Bat Yam, 5962026

  • Soroka Medical Center

    Beersheba, 85025

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Carmel Medical Center

    Haifa, 3436212

  • Edith Wolfson Medical Center

    Holon, 5810001

  • Maccabi Healthcare

    Holon, 5837737

  • Shaarei Zedek Medical Center

    Jerusalem, 91031

  • Research Fund of the Hadassah Medical Organization (R.A.)

    Jerusalem, 9112001

  • Clalit - Jerusalem East

    Jerusalem East, 9103102

  • Meir Medical Center Israel

    Kfar Saba, 4428164

  • Holy Family Hospital

    Nazareth, 16234

  • Rabin Medical Center (Beilinson Hospital)

    Petah Tikva, 4941492

  • Clalit Health Services

    Petah Tikva, 49473

  • Kaplan Medical Center

    Rehovot, 76100

  • Health Corporation of the Ziv Medical Center (R.A.)

    Safed, 13100

  • Clalit - Nazareth

    Tel Aviv, 62098

  • Clalit - Rishon

    Tel Aviv, 62098

  • Clalit - Carmiel

    Tel Aviv

  • Sheba Medical Center

    Tel-Hashomer / Ramat Gan, 5262000

  • PORIYA Medical Center

    Tiberias, 15208

  • Assaf Harofeh MC

    Zrifin, 70300

Other trials in Israel

Slovenia19 sites

  • Internistična ambulanta za pljučne in alergijske bolezni Karmen Kramer Vrščaj

    Celje, 3000

  • Pulmološka ambulanta dr. Snežana Ulčar Kostič s.p.

    Kamnik, 1241

  • MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o.

    Kočevje, 1330

  • VELOG, Zdravstveni center, d.o.o.

    Kranj, 4000

  • Zdravstvene storitve in svetovanje, Tjaša Šubic s.p.

    Kranj, 4000

  • Verboten Kopriva Renata - Ordinacija Interne Medicine

    Litija, 1270

  • Arjana Maček d.o.o

    Ljubljana, 1000

  • Kambič-Kafol d.o.o.

    Ljubljana, 1000

  • Medvital Katarina Vukelič s.p.

    Ljubljana, 1000

  • Alveola, internistični ambulantni diagnostični center d.o.o.

    Maribor, 2000

  • CIIM PLUS, center za interno in interventno medicino, d.o.o.

    Maribor, 2000

  • INTERNIST MB - specialistična ambulantna dejavnost, Marko Bombek s.p.

    Maribor, 2000

  • Zdravstveno svetovanje in storitve, Krstić Zoran, s.p.

    Maribor, 2000

  • Mag. Anton Lopert, dr.med. - Zasebna internistična ambulanta

    Murska Sobota, 9000

  • Zasebna ambulanta za pljučne bolezni, mag. Alojz Horvat, dr. med.

    Murska Sobota, 9000

  • Prim. mag. Šegota Nikša, dr.med., specialistična zdravniška dejavnost, s.p.

    Škofja Vas, 3211

  • Dr. Ana Novakovic

    Velenje, 3320

  • Dr. med. Tomaz Smonkar

    Velenje, 3320

  • Dr. Mikro Lekic

    Velenje, 3320

Other trials in Slovenia

Bulgaria17 sites

  • MBAL Sveti Ivan Rilski-2003

    Dupnitsa, 2600

  • SBALBB "Pencho Semov" - Gabrovo EOOD

    Gabrovo, 5300

  • SBALPFZ Haskovo EOOD

    Haskovo, 6300

  • MBAL Kiro Popov EOOD

    Karlovo, 4300

  • MBAL Sv. Ivan Rilski EOOD

    Kozloduy, 3320

  • MBAL "Prof. Dr P. Stoyanov" AD - Mihail Kirov

    Lovech, 5500

  • Iliana Valkanova

    Plovdiv, 4002

  • MBAL Sveti Panteleimon

    Plovdiv, 4004

  • "Medical Center-Razgrad"OOD

    Razgrad, 7200

  • Medical Center Re Spiro OOD

    Razgrad, 7200

  • MBAL Sliven to VMA Sofia

    Sliven, 8800

  • Grigor Lalov

    Smolyan, 4700

  • SBALPFZ-Sofia district EOOD

    Sofia, 1202

  • Prevencia 2000 MCDMP OOD

    Stara Zagora, 6000

  • Medical Center "Research expert" OOD

    Varna, 9000

  • Medical Center "Tara" OOD

    Veliko Tarnovo, 5000

  • MC"Sv.Ivan Rilski"OOD

    Vidin, 3700

Other trials in Bulgaria

Switzerland7 sites

  • Gruppenpraxis Basel

    Basel, 4051

  • Gruppenpraxis Frick

    Frick, 5070

  • Gruppenpraxis Emmenbrücke

    Geuensee, 6232

  • Berner Reha Zentrum Medizin Pneumologie

    Heiligenschwendi, 3625

  • Gruppenpraxis Luzern

    Lucerne, 6004

  • Spital Linth

    Utznach, 8730

  • Zürcher RehaZentrum Wald

    Wald, 8636

Other trials in Switzerland

Ukraine7 sites

  • Dnipropetrovsk 6 City clinical Hospital

    Dnipropetrovsk, 49074

  • Regional centre of Phtysiology and Pulmonology

    Ivano-Frankivsk, 76018

  • City Clinical Hospital Nr. 13

    Kharkiv, 61001

  • National Institute of Phthisiology and Pulmonology named F. G. Yanovsky National Academy of Medical Sciences of Ukraine

    Kyiv, 3038

  • Volyn Regional Clinical Hospital

    Lutsk, 43000

  • Lviv Regional Phthisiopneumological Clinical Treatment and Diagnostic Center

    Lviv, 79000

  • Vinnytsia City Clinical Hospital Nr. 1

    Vinnitsa, 21029

Other trials in Ukraine

Lithuania5 sites

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, LT- 50161

  • Klaipeda Hospital

    Klaipėda, 92231

  • Enterprise Klaipeda University Hospital

    Klaipėda, 92288

  • Vilnius University Hospital Santaros klinikos

    Vilnius, 8661

  • Public Enterprise Vilnius District Central Outpatient Clinic

    Vilnius, LT-06122

Other trials in Lithuania

About this study

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

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.

Being tested
Spiolto® Respimat®
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spiolto® Respimat®Drug

    Drug

Study groups in NCT03663569
Study groupRoleWhat they receive
subjects with COPDNot described
Receives: Drug: Spiolto® Respimat®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage 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.

    Measured: At Visit 2 (6 weeks after baseline visit 1)

Secondary outcomes (7)

  1. 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. Symptom domain covered 4 questions (number 1, 2, 5, 6), Functional state domain covered 4 questions (number 7, 8, 9, 10), and Mental state domain covered 2 questions (number 3, 4). Scores for the questions in each domain were summed up and divided by the number of questions in each domain giving the resulting score for respective domain. 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.

    Measured: At baseline visit 1 and 6 weeks thereafter at visit 2

  2. 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).

    Measured: At visit 1

  3. 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).

    Measured: At visit 2 (6 weeks after baseline visit 1)

  4. Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2

    Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.

    Measured: At visit 2 (6 weeks after baseline visit 1)

  5. Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2

    Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported

    Measured: At visit 2 (6 weeks after baseline visit 1)

  6. 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.

    Measured: At visit 2 (6 weeks after baseline visit 1)

  7. 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.

    Measured: At visit 2 (6 weeks after baseline visit 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2018
  2. Study start15 Aug 2018
  3. Primary completion4 Oct 2019
  4. Study completion4 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
4,819 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03663569
Sponsor's protocol ID
1237-0072
Status last verified
Dec 2024
First submitted
26 Jul 2018
Last updated
7 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studiesin products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).Requestors can use the following link http://trials.boehringer-ingelheim.com/ to: 1. find information in order to request access to clinical study data, for listed studies. 2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 388 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 388 sites in Russia, Czechia, Poland, Hungary, Romania and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2 (time frame: At Visit 2 (6 weeks after baseline visit 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03663569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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