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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00361959 |
Purpose
This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Tiotropium bromide 18mcg Drug: Fluticasone propionate/ salmeterol combination 50/500mcg |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104 Week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE) 50/500mcg With Tiotropium Bromide 18 Mcg on the Rate of Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD) |
| Estimated Enrollment: | 1270 |
| Study Start Date: | September 2003 |
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| Austria | |
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| Salzburg, Austria, A-5020 | |
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| Grimmenstein, Austria, A-2840 | |
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| Vienna, Austria, A-1120 | |
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| Moedling, Austria, A-2340 | |
| Belgium | |
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| Edegem, Belgium, 2650 | |
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| Leuven, Belgium, 3000 | |
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| Gent, Belgium, 9000 | |
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| Bruxelles, Belgium, 1020 | |
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| Brussels, Belgium, 1000 | |
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| Liege, Belgium, 4000 | |
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| Genk, Belgium, 3600 | |
| Czech Republic | |
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| Blansko, Czech Republic, 678 31 | |
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| Ostrava, Czech Republic, 703 00 | |
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| Plzen, Czech Republic, 326 00 | |
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| Praha 4, Czech Republic, 140 42 | |
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| Olomouc, Czech Republic, 775 20 | |
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| Kyjov, Czech Republic, 697 33 | |
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| Plzen - Bory, Czech Republic, 305 99 | |
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| Praha 8, Czech Republic, 180 81 | |
| Denmark | |
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| Kobenhavn NV, Denmark, DK-2400 | |
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| Aarhus C, Denmark, DK-8000 | |
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| Odense C, Denmark, DK-5000 | |
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| Aalborg, Denmark, DK-9100 | |
| Estonia | |
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| Tartu, Estonia, 51014 | |
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| Paide, Estonia, 72712 | |
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| Tallinn, Estonia, 10138 | |
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| Parnu, Estonia, 80024 | |
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| Tallinn, Estonia, 11619 | |
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| Tallinn, Estonia, 13619 | |
| Germany | |
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| Berlin, Germany, 10585 | |
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| Berlin, Germany, 10367 | |
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| Berlin, Germany, 10559 | |
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| Berlin, Germany, 10965 | |
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| Berlin, Germany, 10178 | |
| Germany, Baden-Wurttemberg | |
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| Weinheim, Baden-Wurttemberg, Germany, 69469 | |
| Germany, Bayern | |
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| Muenchen, Bayern, Germany, 80335 | |
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| Augsburg, Bayern, Germany, 86156 | |
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| Erlangen, Bayern, Germany, 91052 | |
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| Bad Toelz, Bayern, Germany, 83646 | |
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| Bad Woerrishofen, Bayern, Germany, 86825 | |
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| Muenchen, Bayern, Germany, 81677 | |
| Germany, Hessen | |
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| Kassel, Hessen, Germany, 34121 | |
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| Kassel, Hessen, Germany, 34117 | |
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| Eschwege, Hessen, Germany, 37269 | |
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| Gelnhausen, Hessen, Germany, 63571 | |
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| Marburg, Hessen, Germany, 35037 | |
| Germany, Nordrhein-Westfalen | |
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| Bielefeld, Nordrhein-Westfalen, Germany, 33602 | |
| Greece | |
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| Periohi Dragana, Greece, 68100 | |
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| Athens, Greece, 18454 | |
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| Athens, Greece, 15669 | |
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| Kavala, Greece, 65403 | |
| Greece, Crete | |
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| Chania, Crete, Greece, 73300 | |
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| Rethymnon, Crete, Greece, 74100 | |
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| Heraklion, Crete, Greece, 71409 | |
| Italy | |
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| Sesto San Giovanni, Italy, 20099 | |
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| Ferrara, Italy, 44100 | |
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| Foggia, Italy, 71100 | |
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| Telese Terme (BN), Italy, 82037 | |
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| Pisa, Italy, 56124 | |
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| Ascoli Piceno, Italy, 63100 | |
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| Salerno, Italy, 84126 | |
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| Padova, Italy, 35128 | |
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| Rivolta d'Adda, Italy, 26026 | |
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| Cassano Murge, Italy, 70020 | |
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| San Sisto, Italy, 06132 | |
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| Genova, Italy, 16132 | |
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| Eboli (SA), Italy, 84025 | |
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| Milano, Italy, 20142 | |
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| Milano, Italy, 20132 | |
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| Napoli, Italy, 80131 | |
| Latvia | |
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| Riga, Latvia, LV-1002 | |
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| Riga, Latvia, LV-1035 | |
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| Jekabpils, Latvia, LV-5201 | |
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| Riga, Latvia, LV-1079 | |
| Lithuania | |
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| Klaipeda, Lithuania, LT-92288 | |
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| Alytus, Lithuania, LT-62114 | |
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| Kaunas, Lithuania, LT-50009 | |
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| Vilnius, Lithuania, LT-07156 | |
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| Klaipeda, Lithuania, LT-92231 | |
| Netherlands | |
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| Breda, Netherlands, 4819 EV | |
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| Eindhoven, Netherlands, 5623 EJ | |
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| Almere, Netherlands, 1315 RA | |
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| Leiderdorp, Netherlands, 2353 GA | |
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| Arnhem, Netherlands, 6815 AD | |
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| Sneek, Netherlands, 8601 ZK | |
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| Harderwijk, Netherlands, 3844 DG | |
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| Oss, Netherlands, 5342 BT | |
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| Venlo, Netherlands, 5912 BL | |
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| Meppel, Netherlands, 7943 KA | |
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| Hertogenbosch, Netherlands, 5211 NL | |
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| Amsterdam, Netherlands, 1105 AZ | |
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| Zwolle, Netherlands, 8025 AB | |
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| Veldhoven, Netherlands, 5504 DB | |
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| Amsterdam, Netherlands, 1091 AC | |
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| Weert, Netherlands, 6001 BE | |
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| Almelo, Netherlands, 7609 PP | |
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| Amersfoort, Netherlands, 3818 ES | |
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| Hoorn, Netherlands, 1624 NP | |
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| Amsterdam, Netherlands, 1034 CS | |
| Norway | |
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| Kristiansand, Norway, 4615 | |
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| Gjettum, Norway, 1346 | |
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| Trondheim, Norway, 7030 | |
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| Tonsberg, Norway, 3116 | |
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| Fredrikstad, Norway, 1606 | |
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| Moelv, Norway, 2391 | |
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| Bergen, Norway, 5021 | |
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| Oslo, Norway, 0855 | |
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| Oslo, Norway, 1150 | |
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| Trondheim, Norway, 7027 | |
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| Volda, Norway, 6100 | |
| Romania | |
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| Bucuresti, Romania, 010457 | |
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| Deva, Romania, 330021 | |
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| Cluj-Napoca, Romania, 400371 | |
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| Bucharest, Romania, 060338 | |
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| Iasi, Romania, 700115 | |
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| Bucharest, Romania, 050159 | |
| Russian Federation | |
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| Irkutsk, Russian Federation, 664005 | |
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| Moscow, Russian Federation, 105 077 | |
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| St. Petersburg, Russian Federation, 197 089 | |
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| Moscow, Russian Federation, 119 881 | |
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| Moscow, Russian Federation, 105 229 | |
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| Moscow, Russian Federation, 109 240 | |
| Slovakia | |
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| Cadca, Slovakia, 02216 | |
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| Kosice, Slovakia, 04001 | |
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| Prievidza, Slovakia, 97101 | |
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| Bratislava, Slovakia, 85101 | |
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| Bardejov, Slovakia, 08501 | |
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| Bratislava, Slovakia, 84104 | |
| Slovenia | |
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| Litija, Slovenia, 1270 | |
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| Golnik, Slovenia, 4204 | |
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| Topolsica, Slovenia, 3326 | |
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| Hoce, Slovenia, 2311 | |
| Spain | |
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| Madrid, Spain, 28046 | |
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| Santiago de Compostela, Spain, 15706 | |
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| Madrid, Spain, 28041 | |
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| Zaragoza, Spain, 50009 | |
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| Guadalajara, Spain, 19002 | |
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| Figueres, Spain, 17600 | |
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| Barcelona, Spain, 08035 | |
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| Valencia, Spain, 46014 | |
| Spain, Alicante | |
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| San Vicente de Raspeig, Alicante, Spain, 03690 | |
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| Orihuela, Alicante, Spain, 03314 | |
| Spain, Barcelona | |
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| Tarrasa, Barcelona, Spain, 08221 | |
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| Vic, Barcelona, Spain, 08500 | |
| Spain, Vizcaya | |
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| Galdakano, Vizcaya, Spain, 48960 | |
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| Barakaldo, Vizcaya, Spain, 48903 | |
| Sweden | |
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| Karlstad, Sweden, SE-651 85 | |
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| Linkoping, Sweden, SE-581 85 | |
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| Boden, Sweden, SE-961 64 | |
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| Uppsala, Sweden, SE-751 85 | |
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| Orebro, Sweden, SE-701 85 | |
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| Stockholm, Sweden, SE-171 76 | |
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| Eksjo, Sweden, SE-575 81 | |
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| Stockholm, Sweden, SE-141 86 | |
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| Malmo, Sweden, SE-205 02 | |
| Ukraine | |
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| Kiev, Ukraine, 3680 | |
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| Kiev, Ukraine, 0411 2 | |
| United Kingdom | |
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| Newcastle-Upon-Tyne, United Kingdom, NE7 7DN | |
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| Peterborough, United Kingdom, PE3 6DA | |
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| Edinburgh, United Kingdom, EH16 4SA | |
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| Newcastle-Upon-Tyne, United Kingdom, NE4 6BE | |
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| Glasgow, United Kingdom, G31 1ER | |
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| Birmingham, United Kingdom, B15 2TH | |
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| London, United Kingdom, E2 9JX | |
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| Isleworth, United Kingdom, TW7 6AG | |
| United Kingdom, Lancashire | |
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| Liverpool, Lancashire, United Kingdom, L9 7AL | |
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| Manchester, Lancashire, United Kingdom, M8 5RB | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Study ID Numbers: | SCO40036 |
| Study First Received: | August 7, 2006 |
| Last Updated: | August 7, 2006 |
| ClinicalTrials.gov Identifier: | NCT00361959 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
COPD exacerbation fluticasone propionate/salmeterol combination SERETIDE tiotropium |
|
Anti-Inflammatory Agents Parasympatholytics Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cholinergic Agents Adrenergic Agonists Lung Diseases, Obstructive Respiratory Tract Diseases Bromides Therapeutic Uses Fluticasone |
Tiotropium Dermatologic Agents Salmeterol Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents Anticonvulsants Pulmonary Disease, Chronic Obstructive |