Pulmonary Disease, Chronic ObstructiveNCT01006135

Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 864 sites in 6 countries.

Completed

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

Official record

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Trial summary

The objective of this observational study is to collect and evaluate data on Health Related Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in the national samples of Central \& Central European patients with varying severities of chronic obstructive pulmonary disease (COPD) in… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
How many people: 4,852 participants
Where: 864 sitesin 6 countries
Study dates: Oct 2009to Jun 2011
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: patients

Who may be able to join

40 years and older male and female ambulatory outpatients.
Clinical diagnosis of Chronic Obstructive Lung Disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines: Forced expiratory Volume in one second (FEV1)/ Forced Vital Capacity (FVC) < 0.7 and FEV1 < 80% predicted).
Stable patient, without exacerbation for at least one month to the study.

Who cannot join

Uncooperative patients as judged by the physician.
Patients that have any condition which, according to the participating physician's opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation study.
Patients with any conditions excluded as per Country specific package insert.
Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems.

Trial locations and contacts

864 sites in 6 countries.

Country

City, postcode or hospital

726 sites in 6 countries

Poland300 sites

Boehringer Ingelheim Investigational Site 23
Aleksandrów Kujawski
Boehringer Ingelheim Investigational Site 24
Augustów
Boehringer Ingelheim Investigational Site 25
Belsk Duży
Boehringer Ingelheim Investigational Site 26
Biała Prudnicka
Boehringer Ingelheim Investigational Site 27
Bialystok
Boehringer Ingelheim Investigational Site 28
Bialystok
Boehringer Ingelheim Investigational Site 29
Bialystok
Boehringer Ingelheim Investigational Site 30
Bialystok
Boehringer Ingelheim Investigational Site 31
Bialystok
Boehringer Ingelheim Investigational Site 32
Bialystok
Boehringer Ingelheim Investigational Site 33
Bialystok
Boehringer Ingelheim Investigational Site 34
Bialystok
Boehringer Ingelheim Investigational Site 35
Bielawa
Boehringer Ingelheim Investigational Site 36
Bielawa
Boehringer Ingelheim Investigational Site 37
Bielsk
Boehringer Ingelheim Investigational Site 38
Bielsko-Biala
Boehringer Ingelheim Investigational Site 39
Biskupcu
Boehringer Ingelheim Investigational Site 40
Bochnia
Boehringer Ingelheim Investigational Site 41
Bolesław
Boehringer Ingelheim Investigational Site 42
Bolesławiec
Boehringer Ingelheim Investigational Site 43
Brodnica
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Brzesko
Boehringer Ingelheim Investigational Site 45
Brzeziny
Boehringer Ingelheim Investigational Site 46
Bydgoszcz
Boehringer Ingelheim Investigational Site 47
Bydgoszcz
Boehringer Ingelheim Investigational Site 48
Bydgoszcz
Boehringer Ingelheim Investigational Site 49
Bydgoszcz
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Bydgoszcz
Boehringer Ingelheim Investigational Site 51
Bystra
Boehringer Ingelheim Investigational Site 52
Bystra
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Bytom
Boehringer Ingelheim Investigational Site 54
Bytom
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Cewice
Boehringer Ingelheim Investigational Site 56
Chęciny
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Chełm
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Chełmno
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Chełmża
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Chodzież
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Chojnice
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Chorzów
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Chorzów
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Chorzów
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Chrzanów
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Ciechanów
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Ciechanów
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Cieszyn
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Czechowice-Dziedzice
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Czerwin
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Częstochowa
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Częstochowa
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Częstochowa
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Czluchów
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Dabrowa Górnicza
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Dabrowa Górnicza
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Dabrowa Górnicza
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Dabrowa Niemodlinska
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Dobrzechów
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Dobrzeń Wielki
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Dziergowice
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Dzierzenin
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Elblag
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Elblag
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Elblag
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Ełk
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Garwolin
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Garwolin
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Gdansk
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Gdansk
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Gdansk
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Gdansk
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Gdansk
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Gdansk
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Gdynia
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Gdynia
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Gierałtowice
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Giżycko
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Gliwice
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Gliwice
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Gliwice
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Glogów
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Glogów
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Glogów
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Głuchołazy
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Głuchołazy
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Gmina Koszęcin
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Gmina Poddębice
Boehringer Ingelheim Investigational Site 334
Gmina Śrem
Boehringer Ingelheim Investigational Site 352
Gmina Świecie
Boehringer Ingelheim Investigational Site 375
Gmina Uchanie
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Gniezno
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Gniezno
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Golub-Dobrzyń
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Gorlice
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Górno
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Gorzów Wlkp
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Gorzów Wlkp
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Grodzisk Mazowiecki
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Grodzisk Mazowiecki
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Grodzisk Wielkopolski
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Grójec
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Grudziądz
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Grudziądz
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Gryfice
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Hajnówka
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Hrubieszów
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Iława
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Inowrocław
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Inowrocław
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Inowrocław
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Jarosław
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Jaroszowiec
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Jasło
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Jasło
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Jasło
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Jastrzębie Zdrój
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Jastrzębie Zdrój
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Jaworzno
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Jejkowice
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Kalej
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Katowice
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Katowice
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Katowice
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Katowice
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Katowice
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Katowice
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Katowice
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Katowice
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Kędzierzyn-Koźle
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Kępno
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Kielce
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Kielce
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Kielce
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Kłodawa
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Kłodawa
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Kłodzko
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Kłodzko
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Kołobrzeg
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Komorniki
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Konin
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Konin
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Kórnik
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Koszalin
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Kowary
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Kozienice
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Krakow
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Krakow
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Krakow
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Krakow
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Krakow
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Krakow
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Kraśnik
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Krosno
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Krosno
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Krzeszowice
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Kutno
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Łańcut
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Lębork
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Lębork
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Legionowo
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Legionowo
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Legnica
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Lipsko
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Lódz
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Lódz
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Lódz
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Lódz
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Lódz
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Lódz
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Łomża
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Lowicz
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Lubin
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Lubin
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Lubin
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Lublin
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Lubliniec
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Lubomierz
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Makow Maz
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Malanów
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Malbork
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Małdyty
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Marki
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Miechów
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Międzyrzecz
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Mielec
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Mielec
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Morąg
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Myślenice
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Mysłowice
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Myszków
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Nasielsk
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Nisko
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Niwiski
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Nowa Dęba
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Nowa Dęba
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Nowy Dwór Maz
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Nowy Sącz
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Nowy Sącz
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Nowy Sącz
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Nowy Sącz
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Nowy Tomyśl
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Oborniki
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Oława
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Oława
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Oława
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Oleśnica
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Oleśnica
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Oleśnica
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Olesno
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Olesno
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Olkusz
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Olsztyn
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Olsztyn
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Olsztyn
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Opatów
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Opoczno
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Opole
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Opole
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Opole
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Opole
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Opole
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Orzese
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Ostrowiec/Sandomierz
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Oświęcim
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Otwock
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Otwock
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Otwock
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Pabianice
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Pabianice
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Pajęczno
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Piła
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Piła
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Pinczów
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Piotrkow Tybunalski
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Pleszew
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Płock
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Płock
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Płock
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Polanica-Zdrój
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Poznan
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Poznan
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Poznan
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Poznan
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Poznan
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Poznan
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Poznan
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Poznan
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Poznan
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Poznan
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Poznan
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Prabuty
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Proszowice
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Proszowice
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Proszowice
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Przemyśl
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Przemyśl
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Pszczyna
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Puck
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Puławy
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Racibórz
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Racibórz
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Radlin
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Radom
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Radom
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Radom
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Radomsko
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Radomsko
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Radomsko
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Radziejów
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Rawa Mazowiecka
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Rawicz
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Rawicz
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Reda
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Rodzinna
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Rokitno
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Ruda Śląska
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Rumia
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Rybnik
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Rypin
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Rzeszów
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Rzeszów
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Sanok
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Sejny
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Siedlce
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Siemianowice Śląskie
Boehringer Ingelheim Investigational Site 318
Sieradz
Boehringer Ingelheim Investigational Site 319
Skąpe

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Russia188 sites

Boehringer Ingelheim Investigational Site 547
Astrakhan
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Astrakhan
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Barnaul
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Belgorod
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Chelyabinsk
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Chelyabinsk
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Chelyabinsk
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Dinskaya
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Engel's
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Gatchina
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Izhevsk
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Izhevsk
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Kaluga
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Kaluga
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Kaluga
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Kazan'
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Kazan'
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Kazan'
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Kemerovo
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Kemerovo
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Kemerovo
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Kemerovo
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Kemerovo
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Khabarovsk
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Khabarovsk
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Kirov
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Klintsy of Bryansk Region
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Krasnodar
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Krasnodar
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Krasnodar
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Krasnoyarsk
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Krasnoyarsk
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Magnitogorsk
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Mine
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Nizhny Tagil
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Noginsk
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Boehringer Ingelheim Investigational Site 651
Novosibirsk
Boehringer Ingelheim Investigational Site 652
Novosibirsk
Boehringer Ingelheim Investigational Site 653
Novosibirsk
Boehringer Ingelheim Investigational Site 654
Odintsovo
Boehringer Ingelheim Investigational Site 655
Omsk
Boehringer Ingelheim Investigational Site 656
Orenburg
Boehringer Ingelheim Investigational Site 657
Orenburg
Boehringer Ingelheim Investigational Site 658
Penza
Boehringer Ingelheim Investigational Site 659
Penza
Boehringer Ingelheim Investigational Site 660
Perm
Boehringer Ingelheim Investigational Site 661
Perm
Boehringer Ingelheim Investigational Site 662
Perm
Boehringer Ingelheim Investigational Site 663
Pushkino
Boehringer Ingelheim Investigational Site 664
Pyatigorsk
Boehringer Ingelheim Investigational Site 665
Ramenskoye
Boehringer Ingelheim Investigational Site 666
Rostov-on-Donu
Boehringer Ingelheim Investigational Site 667
Rostov-on-Donu
Boehringer Ingelheim Investigational Site 668
Rostov-on-Donu
Boehringer Ingelheim Investigational Site 669
Rostov-on-Donu
Boehringer Ingelheim Investigational Site 670
Ryazan
Boehringer Ingelheim Investigational Site 671
Ryazan
Boehringer Ingelheim Investigational Site 672
Saint Petersburg
Boehringer Ingelheim Investigational Site 673
Saint Petersburg
Boehringer Ingelheim Investigational Site 674
Saint Petersburg
Boehringer Ingelheim Investigational Site 675
Saint Petersburg
Boehringer Ingelheim Investigational Site 676
Saint Petersburg
Boehringer Ingelheim Investigational Site 677
Saint Petersburg
Boehringer Ingelheim Investigational Site 678
Saint Petersburg
Boehringer Ingelheim Investigational Site 679
Saint Petersburg
Boehringer Ingelheim Investigational Site 680
Saint Petersburg
Boehringer Ingelheim Investigational Site 681
Saint Petersburg
Boehringer Ingelheim Investigational Site 682
Saint Petersburg
Boehringer Ingelheim Investigational Site 683
Saint Petersburg
Boehringer Ingelheim Investigational Site 684
Saint Petersburg
Boehringer Ingelheim Investigational Site 685
Saint Petersburg
Boehringer Ingelheim Investigational Site 686
Samara
Boehringer Ingelheim Investigational Site 687
Samara
Boehringer Ingelheim Investigational Site 688
Saratov
Boehringer Ingelheim Investigational Site 689
Saratov
Boehringer Ingelheim Investigational Site 690
Saratov
Boehringer Ingelheim Investigational Site 691
Saratov
Boehringer Ingelheim Investigational Site 692
Saratov
Boehringer Ingelheim Investigational Site 693
Saratov
Boehringer Ingelheim Investigational Site 694
Saratov
Boehringer Ingelheim Investigational Site 695
Smolensk
Boehringer Ingelheim Investigational Site 696
Sochi
Boehringer Ingelheim Investigational Site 697
Stavropol
Boehringer Ingelheim Investigational Site 698
Stavropol
Boehringer Ingelheim Investigational Site 699
Stavropol
Boehringer Ingelheim Investigational Site 700
Surgut
Boehringer Ingelheim Investigational Site 701
Taganrog
Boehringer Ingelheim Investigational Site 702
Tolyatti
Boehringer Ingelheim Investigational Site 703
Tolyatti
Boehringer Ingelheim Investigational Site 704
Tolyatti
Boehringer Ingelheim Investigational Site 705
Tomsk
Boehringer Ingelheim Investigational Site 706
Tomsk
Boehringer Ingelheim Investigational Site 707
Tomsk
Boehringer Ingelheim Investigational Site 708
Tomsk
Boehringer Ingelheim Investigational Site 709
Tula
Boehringer Ingelheim Investigational Site 712
Tver'
Boehringer Ingelheim Investigational Site 710
Tyumen
Boehringer Ingelheim Investigational Site 711
Tyumen
Boehringer Ingelheim Investigational Site 713
Ufa
Boehringer Ingelheim Investigational Site 714
Ufa
Boehringer Ingelheim Investigational Site 715
Ufa
Boehringer Ingelheim Investigational Site 716
Ufa
Boehringer Ingelheim Investigational Site 717
Ufa
Boehringer Ingelheim Investigational Site 718
Ufa
Boehringer Ingelheim Investigational Site 719
Ulan-Ude
Boehringer Ingelheim Investigational Site 720
Ulan-Ude
Boehringer Ingelheim Investigational Site 721
Ulyanovsk
Boehringer Ingelheim Investigational Site 722
Ulyanovsk
Boehringer Ingelheim Investigational Site 723
Vladikavkaz
Boehringer Ingelheim Investigational Site 724
Vladimir
Boehringer Ingelheim Investigational Site 725
Vladimir
Boehringer Ingelheim Investigational Site 726
Volgograd
Boehringer Ingelheim Investigational Site 727
Volgograd
Boehringer Ingelheim Investigational Site 728
Volgograd
Boehringer Ingelheim Investigational Site 729
Voronezh
Boehringer Ingelheim Investigational Site 730
Voronezh
Boehringer Ingelheim Investigational Site 731
Voronezh
Boehringer Ingelheim Investigational Site 732
Yaroslavl
Boehringer Ingelheim Investigational Site 556
Yekaterinburg
Boehringer Ingelheim Investigational Site 557
Yekaterinburg
Boehringer Ingelheim Investigational Site 558
Yekaterinburg
Boehringer Ingelheim Investigational Site 559
Yekaterinburg
Boehringer Ingelheim Investigational Site 560
Yekaterinburg
Boehringer Ingelheim Investigational Site 733
Zheleznogorsk
Boehringer Ingelheim Investigational Site 734
Zheleznogorsk

Other trials in Russia

Slovakia93 sites

Boehringer Ingelheim Investigational Site 735
Banská Bystrica
Boehringer Ingelheim Investigational Site 736
Banská Bystrica
Boehringer Ingelheim Investigational Site 737
Banská Bystrica
Boehringer Ingelheim Investigational Site 738
Bardejov
Boehringer Ingelheim Investigational Site 739
Bardejov
Boehringer Ingelheim Investigational Site 740
Bojnice
Boehringer Ingelheim Investigational Site 741
Bratislava
Boehringer Ingelheim Investigational Site 742
Bratislava
Boehringer Ingelheim Investigational Site 743
Bratislava
Boehringer Ingelheim Investigational Site 744
Bratislava
Boehringer Ingelheim Investigational Site 745
Bratislava
Boehringer Ingelheim Investigational Site 746
Bratislava
Boehringer Ingelheim Investigational Site 747
Bratislava
Boehringer Ingelheim Investigational Site 748
Bratislava
Boehringer Ingelheim Investigational Site 749
Brezno
Boehringer Ingelheim Investigational Site 750
Brezno
Boehringer Ingelheim Investigational Site 751
Čadca
Boehringer Ingelheim Investigational Site 752
Galanta
Boehringer Ingelheim Investigational Site 753
Hurbanovo
Boehringer Ingelheim Investigational Site 754
Ilava
Boehringer Ingelheim Investigational Site 755
Kežmarok
Boehringer Ingelheim Investigational Site 756
Košice
Boehringer Ingelheim Investigational Site 757
Košice
Boehringer Ingelheim Investigational Site 758
Košice
Boehringer Ingelheim Investigational Site 759
Košice
Boehringer Ingelheim Investigational Site 760
Košice
Boehringer Ingelheim Investigational Site 761
Košice
Boehringer Ingelheim Investigational Site 762
Košice
Boehringer Ingelheim Investigational Site 763
Krompachy
Boehringer Ingelheim Investigational Site 764
Kysúcke Nové Mesto
Boehringer Ingelheim Investigational Site 765
Levice
Boehringer Ingelheim Investigational Site 766
Levoča
Boehringer Ingelheim Investigational Site 767
Liptovský Hrádok
Boehringer Ingelheim Investigational Site 768
Lučenec
Boehringer Ingelheim Investigational Site 769
Lučenec
Boehringer Ingelheim Investigational Site 770
Lučenec
Boehringer Ingelheim Investigational Site 771
Malacky
Boehringer Ingelheim Investigational Site 772
Martin
Boehringer Ingelheim Investigational Site 773
Martin
Boehringer Ingelheim Investigational Site 774
Medzilaborce
Boehringer Ingelheim Investigational Site 775
Michalovce
Boehringer Ingelheim Investigational Site 776
Michalovce
Boehringer Ingelheim Investigational Site 777
Michalovce
Boehringer Ingelheim Investigational Site 778
Moldava nad Bodvou
Boehringer Ingelheim Investigational Site 779
Myjava
Boehringer Ingelheim Investigational Site 780
Nitra
Boehringer Ingelheim Investigational Site 781
Nitra
Boehringer Ingelheim Investigational Site 782
Nitra
Boehringer Ingelheim Investigational Site 783
Nová Bana
Boehringer Ingelheim Investigational Site 784
Nováky
Boehringer Ingelheim Investigational Site 785
Nové Mesto nad Váhom
Boehringer Ingelheim Investigational Site 786
Nové Mesto nad Váhom
Boehringer Ingelheim Investigational Site 787
Nové Zámky
Boehringer Ingelheim Investigational Site 788
Nové Zámky
Boehringer Ingelheim Investigational Site 789
Nové Zámky
Boehringer Ingelheim Investigational Site 790
Poprad
Boehringer Ingelheim Investigational Site 791
Povazská Bystrica
Boehringer Ingelheim Investigational Site 792
Prešov
Boehringer Ingelheim Investigational Site 793
Prešov
Boehringer Ingelheim Investigational Site 794
Prievidza
Boehringer Ingelheim Investigational Site 795
Prievidza
Boehringer Ingelheim Investigational Site 796
Rimavská Sobota
Boehringer Ingelheim Investigational Site 797
Rimavská Sobota
Boehringer Ingelheim Investigational Site 798
Rožňava
Boehringer Ingelheim Investigational Site 799
Rožňava
Boehringer Ingelheim Investigational Site 800
Šamorín
Boehringer Ingelheim Investigational Site 801
Senec
Boehringer Ingelheim Investigational Site 802
Sereď
Boehringer Ingelheim Investigational Site 803
Skalica
Boehringer Ingelheim Investigational Site 804
Snina
Boehringer Ingelheim Investigational Site 805
Sp. Nová Ves
Boehringer Ingelheim Investigational Site 806
Sp. Nová Ves
Boehringer Ingelheim Investigational Site 807
Stará Lubovna
Boehringer Ingelheim Investigational Site 808
Stropkov
Boehringer Ingelheim Investigational Site 809
Stúrovo
Boehringer Ingelheim Investigational Site 810
Šurany
Boehringer Ingelheim Investigational Site 811
Svidník
Boehringer Ingelheim Investigational Site 812
Topoľčany
Boehringer Ingelheim Investigational Site 813
Trebišov
Boehringer Ingelheim Investigational Site 814
Trenčín
Boehringer Ingelheim Investigational Site 815
Trnava
Boehringer Ingelheim Investigational Site 816
Trnava
Boehringer Ingelheim Investigational Site 817
Trstená
Boehringer Ingelheim Investigational Site 818
Velké Kapusany
Boehringer Ingelheim Investigational Site 819
Velký Krtis
Boehringer Ingelheim Investigational Site 820
Vráble
Boehringer Ingelheim Investigational Site 821
Vranov n/Toplou
Boehringer Ingelheim Investigational Site 822
Vranov n/Toplou
Boehringer Ingelheim Investigational Site 823
Žiar nad Hronom
Boehringer Ingelheim Investigational Site 824
Žilina
Boehringer Ingelheim Investigational Site 825
Zvolen
Boehringer Ingelheim Investigational Site 826
Zvolen
Boehringer Ingelheim Investigational Site 827
Zvolen

Other trials in Slovakia

Romania86 sites

Boehringer Ingelheim Investigational Site 461
Arad
Boehringer Ingelheim Investigational Site 462
Bacau
Boehringer Ingelheim Investigational Site 463
Bacau
Boehringer Ingelheim Investigational Site 464
Bacau
Boehringer Ingelheim Investigational Site 465
Baia Mare
Boehringer Ingelheim Investigational Site 466
Bârlad
Boehringer Ingelheim Investigational Site 467
Botoșani
Boehringer Ingelheim Investigational Site 468
Brăila
Boehringer Ingelheim Investigational Site 469
Brasov
Boehringer Ingelheim Investigational Site 470
Brasov
Boehringer Ingelheim Investigational Site 471
Breaza
Boehringer Ingelheim Investigational Site 472
Bucharest
Boehringer Ingelheim Investigational Site 473
Bucharest
Boehringer Ingelheim Investigational Site 474
Bucharest
Boehringer Ingelheim Investigational Site 475
Bucharest
Boehringer Ingelheim Investigational Site 476
Bucharest
Boehringer Ingelheim Investigational Site 477
Bucharest
Boehringer Ingelheim Investigational Site 478
Bucharest
Boehringer Ingelheim Investigational Site 479
Bucharest
Boehringer Ingelheim Investigational Site 480
Bucharest
Boehringer Ingelheim Investigational Site 481
Bucharest
Boehringer Ingelheim Investigational Site 482
Bucharest
Boehringer Ingelheim Investigational Site 483
Bucharest
Boehringer Ingelheim Investigational Site 484
Bucharest
Boehringer Ingelheim Investigational Site 485
Buzău
Boehringer Ingelheim Investigational Site 486
Buzău
Boehringer Ingelheim Investigational Site 487
Câmpina
Boehringer Ingelheim Investigational Site 488
Campulung Muscel
Boehringer Ingelheim Investigational Site 489
Cluj-Napoca
Boehringer Ingelheim Investigational Site 490
Cluj-Napoca
Boehringer Ingelheim Investigational Site 491
Cluj-Napoca
Boehringer Ingelheim Investigational Site 492
Cluj-Napoca
Boehringer Ingelheim Investigational Site 493
Cluj-Napoca
Boehringer Ingelheim Investigational Site 494
Cluj-Napoca
Boehringer Ingelheim Investigational Site 495
Cluj-Napoca
Boehringer Ingelheim Investigational Site 496
Constanța
Boehringer Ingelheim Investigational Site 497
Constanța
Boehringer Ingelheim Investigational Site 498
Constanța
Boehringer Ingelheim Investigational Site 499
Constanța
Boehringer Ingelheim Investigational Site 500
Craiova
Boehringer Ingelheim Investigational Site 501
Craiova
Boehringer Ingelheim Investigational Site 502
Craiova
Boehringer Ingelheim Investigational Site 503
Deva
Boehringer Ingelheim Investigational Site 504
Drajna de Jos
Boehringer Ingelheim Investigational Site 505
Drobeta-Turnu Severin
Boehringer Ingelheim Investigational Site 506
Galati
Boehringer Ingelheim Investigational Site 507
Galati
Boehringer Ingelheim Investigational Site 508
Galati
Boehringer Ingelheim Investigational Site 509
Galati
Boehringer Ingelheim Investigational Site 510
Galati
Boehringer Ingelheim Investigational Site 511
Giurgiu
Boehringer Ingelheim Investigational Site 512
Hunedoara
Boehringer Ingelheim Investigational Site 513
Iași
Boehringer Ingelheim Investigational Site 514
Iași
Boehringer Ingelheim Investigational Site 515
Iași
Boehringer Ingelheim Investigational Site 516
Iași
Boehringer Ingelheim Investigational Site 517
Leordeni
Boehringer Ingelheim Investigational Site 518
Marghita
Boehringer Ingelheim Investigational Site 519
Mures
Boehringer Ingelheim Investigational Site 520
Mures
Boehringer Ingelheim Investigational Site 521
Mures
Boehringer Ingelheim Investigational Site 522
Neamt
Boehringer Ingelheim Investigational Site 523
Onești
Boehringer Ingelheim Investigational Site 524
Oradea
Boehringer Ingelheim Investigational Site 525
Oradea
Boehringer Ingelheim Investigational Site 526
Oradea
Boehringer Ingelheim Investigational Site 527
Piteşti
Boehringer Ingelheim Investigational Site 528
Piteşti
Boehringer Ingelheim Investigational Site 529
Ploieşti
Boehringer Ingelheim Investigational Site 530
Ploieşti
Boehringer Ingelheim Investigational Site 531
Ploieşti
Boehringer Ingelheim Investigational Site 532
Râmnicu Vâlcea
Boehringer Ingelheim Investigational Site 533
Râmnicu Vâlcea
Boehringer Ingelheim Investigational Site 534
Roșiorii de Vede
Boehringer Ingelheim Investigational Site 535
Satu Mare
Boehringer Ingelheim Investigational Site 536
Scorniceşti
Boehringer Ingelheim Investigational Site 537
Scorniceşti
Boehringer Ingelheim Investigational Site 538
Suceava
Boehringer Ingelheim Investigational Site 539
Suceava
Boehringer Ingelheim Investigational Site 540
Suceava
Boehringer Ingelheim Investigational Site 541
Targoviste
Boehringer Ingelheim Investigational Site 542
Targoviste
Boehringer Ingelheim Investigational Site 543
Timișoara
Boehringer Ingelheim Investigational Site 544
Timișoara
Boehringer Ingelheim Investigational Site 545
Timișoara
Boehringer Ingelheim Investigational Site 546
Zalău

Other trials in Romania

Slovenia37 sites

Boehringer Ingelheim Investigational Site 828
Celje
Boehringer Ingelheim Investigational Site 829
Celje
Boehringer Ingelheim Investigational Site 830
Celje
Boehringer Ingelheim Investigational Site 831
Celje
Boehringer Ingelheim Investigational Site 832
Celje
Boehringer Ingelheim Investigational Site 833
Domžale
Boehringer Ingelheim Investigational Site 834
Golnik
Boehringer Ingelheim Investigational Site 835
Grosuplje
Boehringer Ingelheim Investigational Site 836
Jesenice
Boehringer Ingelheim Investigational Site 837
Kamnik
Boehringer Ingelheim Investigational Site 838
Kočevje
Boehringer Ingelheim Investigational Site 839
Koper
Boehringer Ingelheim Investigational Site 840
Kranj
Boehringer Ingelheim Investigational Site 841
Kranj
Boehringer Ingelheim Investigational Site 842
Litija
Boehringer Ingelheim Investigational Site 843
Ljubljana
Boehringer Ingelheim Investigational Site 844
Ljubljana
Boehringer Ingelheim Investigational Site 845
Ljubljana
Boehringer Ingelheim Investigational Site 846
Ljubljana
Boehringer Ingelheim Investigational Site 847
Maribor
Boehringer Ingelheim Investigational Site 848
Maribor
Boehringer Ingelheim Investigational Site 849
Maribor
Boehringer Ingelheim Investigational Site 850
Murska Sobota
Boehringer Ingelheim Investigational Site 851
Murska Sobota
Boehringer Ingelheim Investigational Site 852
Murska Sobota
Boehringer Ingelheim Investigational Site 853
Nova Gorica
Boehringer Ingelheim Investigational Site 854
Portorož
Boehringer Ingelheim Investigational Site 855
Ptuj
Boehringer Ingelheim Investigational Site 856
Ptuj
Boehringer Ingelheim Investigational Site 857
Radovljica
Boehringer Ingelheim Investigational Site 858
Ravne na Koroskem
Boehringer Ingelheim Investigational Site 859
Sežana
Boehringer Ingelheim Investigational Site 860
Sežana
Boehringer Ingelheim Investigational Site 861
Slovenj Gradec
Boehringer Ingelheim Investigational Site 862
Slovenska Bistrica
Boehringer Ingelheim Investigational Site 863
Velenje
Boehringer Ingelheim Investigational Site 864
Vrhnika

Other trials in Slovenia

Croatia22 sites

Boehringer Ingelheim Investigational Site 1
Drniš
Boehringer Ingelheim Investigational Site 2
Ivani? Grad-Zagreb
Boehringer Ingelheim Investigational Site 3
Karlovac
Boehringer Ingelheim Investigational Site 4
Knin
Boehringer Ingelheim Investigational Site 5
Metkovi?
Boehringer Ingelheim Investigational Site 6
Osijek
Boehringer Ingelheim Investigational Site 7
Osijek
Boehringer Ingelheim Investigational Site 8
Petrinja-Sisak
Boehringer Ingelheim Investigational Site 9
Požega
Boehringer Ingelheim Investigational Site 10
Pula
Boehringer Ingelheim Investigational Site 11
Rijeka
Boehringer Ingelheim Investigational Site 12
Rijeka
Boehringer Ingelheim Investigational Site 13
Samobor
Boehringer Ingelheim Investigational Site 14
Senj
Boehringer Ingelheim Investigational Site 15
Šibenik
Boehringer Ingelheim Investigational Site 16
Slavonski Brod
Boehringer Ingelheim Investigational Site 17
Vinkovci
Boehringer Ingelheim Investigational Site 18
Virovitica
Boehringer Ingelheim Investigational Site 19
Vukovar
Boehringer Ingelheim Investigational Site 20
Zadar
Boehringer Ingelheim Investigational Site 21
Zagreb
Boehringer Ingelheim Investigational Site 22
Zagreb

Other trials in Croatia

About this study

Read the detailed description

Study Design:

an open-label, uncontrolled and single arm post-marketing surveillance study

Conditions: Pulmonary Disease, Chronic Obstructive
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.

Study groups in NCT01006135
Study group	Role	What they receive
COPD patients		Not described

What is being measured

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

Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Measured: Baseline and 6 months

Secondary outcomes (3)

Additional Bronchodilator or Inhaled Corticosteroids (ICS)
Pulmonary medication from baseline to visit 3 (6 months)
Measured: 6 months
Compliance of Patients
Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10.
Measured: 6 months
Patients With Any Adverse Events
Measured: 6 months

Timeline

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

Oct 2009Jun 2011

First posted2 Nov 2009 (estimated)
Study startOct 2009
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 4,852 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01006135
Sponsor's protocol ID: 205.450
Status last verified: Mar 2014
First submitted: 30 Oct 2009
Last updated: 10 Apr 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Flezar M, Jahnz-Rozyk K, Enache G, Martynenko T, Kristufek P, Skrinjaric-Cincar S, Kadlecova P, Martinovic G. SOSPES: SPIRIVA(R) observational study measuring SGRQ score in routine medical practice in Central and Eastern Europe. Int J Chron Obstruct Pulmon Dis. 2013;8:483-92. doi: 10.2147/COPD.S45640. Epub 2013 Oct 9.
PubMed 24159258

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Active, not recruitingPhase 2
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
COPD (Chronic Obstructive Pulmonary Disease)

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region
ClinicalTrials.gov ID: NCT01006135
Acronym / sponsor ID: 205.450
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 4,852 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 2 Nov 2009 (estimated)
Results: Posted 9 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design:

an open-label, uncontrolled and single arm post-marketing surveillance study

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
COPD patients	–	–

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients

Key inclusion criteria (3 listed)

40 years and older male and female ambulatory outpatients.
Clinical diagnosis of Chronic Obstructive Lung Disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines: Forced expiratory Volume in one second (FEV1)/ Forced Vital Capacity (FVC) < 0.7 and FEV1 < 80% predicted).
Stable patient, without exacerbation for at least one month to the study.

Key exclusion criteria (4 listed)

Uncooperative patients as judged by the physician.
Patients that have any condition which, according to the participating physician's opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation study.
Patients with any conditions excluded as per Country specific package insert.
Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline
Time frame: Baseline and 6 months
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)

3 secondary outcomes

Additional Bronchodilator or Inhaled Corticosteroids (ICS)
Time frame: 6 months
Compliance of Patients
Time frame: 6 months
Patients With Any Adverse Events
Time frame: 6 months

Results and safety

Results posted to the registry on 9 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Treated With Spiriva	4,852	4,712

Primary outcome: Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	Patients Treated With Spiriva n = 4335
Value	-21.73 (19.09)

Population analysed: Patients from the treated set (TS) who have evaluable SGRQ measurements at baseline and Visit 3 (6 months)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Treated With Spiriva	15 of 4,852 (0.3%)	0 of 4,852 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24159258Flezar M, Jahnz-Rozyk K, Enache G, Martynenko T, Kristufek P, Skrinjaric-Cincar S, Kadlecova P, Martinovic G. SOSPES: SPIRIVA(R) observational study measuring SGRQ score in routine medical practice in Central and Eastern Europe. Int J Chron Obstruct Pulmon Dis. 2013;8:483-92. doi: 10.2147/COPD.S45640. Epub 2013 Oct 9.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

864 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 864 sites in 6 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 4 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 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 864 sites in Poland, Russia, Slovakia, Romania, Slovenia and 1 more country. 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 9 Jul 2012). 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?

Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline (time frame: Baseline and 6 months). 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 NCT01006135, which also lists 1 linked publication.

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 10 Apr 2014.