SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Tiotropium bromide 18mcg (Drug); Fluticasone propionate/ salmeterol combination 50/500mcg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

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)

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Rate of healthcare utilisation based exacerbations of COPD

Secondary outcome: Rates for exacerbations based on symptoms, treatment with oral corticosteroids and for antibiotics Time to next exacerbation, duration and difference between healthcare utilisation and symptom based exacerbation

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Established clinical history of moderate to severe COPD.

- Post bronchodilator FEV1 of < 50% of predicted normal.

- FEV1 / FVC ratio <70%.

- Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1.

- Free from exacerbation in the 6 weeks prior to screening.

- Current or former smoker with a smoking history of = 10 pack-years and has a history

of COPD exacerbations.

Exclusion criteria:

- Current asthma, eczema, atopic dermatitis and/or allergic rhinitis.

- Has a known respiratory disorder other than COPD (e. g. lung cancer, sarcoidosis,

tuberculosis or lung fibrosis).

- Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the

bladder that in the opinion of the investigator should prevent the subject from entering the study.

- Has undergone lung transplantation and/or lung volume reduction.

- Female who is a nursing mother.

- Requires regular (daily) long-term oxygen therapy (LTOT).

- Is receiving beta-blockers (except eye drops).

- Has a serious, uncontrolled disease likely to interfere with the study.

- Has received any other investigational drugs within the 4 weeks prior to Visit 1.

- Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.

- Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids,

anticholinergic agents or any components of the formulations (e. g. lactose or milk protein).

GSK Clinical Trials - Call centre, Salzburg A-5020, Austria

GSK Clinical Trials - Call centre, Grimmenstein A-2840, Austria

GSK Clinical Trials - Call centre, Vienna A-1120, Austria

GSK Clinical Trials - Call centre, Moedling A-2340, Austria

GSK Clinical Trials - Call centre, Edegem 2650, Belgium

GSK Clinical Trials - Call centre, Liege 4000, Belgium

GSK Clinical Trials - Call centre, Gent 9000, Belgium

GSK Clinical Trials - Call centre, Bruxelles 1020, Belgium

GSK Clinical Trials - Call centre, Brussels 1000, Belgium

GSK Clinical Trials - Call centre, Leuven 3000, Belgium

GSK Clinical Trials - Call centre, Genk 3600, Belgium

GSK Clinical Trials - Call centre, Blansko 678 31, Czech Republic

GSK Clinical Trials - Call centre, Ostrava 703 00, Czech Republic

GSK Clinical Trials - Call centre, Plzen 326 00, Czech Republic

GSK Clinical Trials - Call centre, Praha 4 140 42, Czech Republic

GSK Clinical Trials - Call centre, Olomouc 775 20, Czech Republic

GSK Clinical Trials - Call centre, Kyjov 697 33, Czech Republic

GSK Clinical Trials - Call centre, Plzen - Bory 305 99, Czech Republic

GSK Clinical Trials - Call centre, Praha 8 180 81, Czech Republic

GSK Clinical Trials - Call centre, Kobenhavn NV DK-2400, Denmark

GSK Clinical Trials - Call centre, Aarhus C DK-8000, Denmark

GSK Clinical Trials - Call centre, Odense C DK-5000, Denmark

GSK Clinical Trials - Call centre, Aalborg DK-9100, Denmark

GSK Clinical Trials - Call centre, Tartu 51014, Estonia

GSK Clinical Trials - Call centre, Paide 72712, Estonia

GSK Clinical Trials - Call centre, Tallinn 10138, Estonia

GSK Clinical Trials - Call centre, Parnu 80024, Estonia

GSK Clinical Trials - Call centre, Tallinn 11619, Estonia

GSK Clinical Trials - Call centre, Tallinn 13619, Estonia

GSK Clinical Trials - Call centre, Berlin 10585, Germany

GSK Clinical Trials - Call centre, Berlin 10367, Germany

GSK Clinical Trials - Call centre, Berlin 10559, Germany

GSK Clinical Trials - Call centre, Berlin 10965, Germany

GSK Clinical Trials - Call centre, Berlin 10178, Germany

GSK Clinical Trials - Call centre, Periohi Dragana 68100, Greece

GSK Clinical Trials - Call centre, Athens 18454, Greece

GSK Clinical Trials - Call centre, Athens 15669, Greece

GSK Clinical Trials - Call centre, Kavala 65403, Greece

GSK Clinical Trials - Call centre, Sesto San Giovanni 20099, Italy

GSK Clinical Trials - Call centre, Ferrara 44100, Italy

GSK Clinical Trials - Call centre, Foggia 71100, Italy

GSK Clinical Trials - Call centre, Padova 35128, Italy

GSK Clinical Trials - Call centre, Pisa 56124, Italy

GSK Clinical Trials - Call centre, Ascoli Piceno 63100, Italy

GSK Clinical Trials - Call centre, Salerno 84126, Italy

GSK Clinical Trials - Call centre, Telese Terme (BN) 82037, Italy

GSK Clinical Trials - Call centre, Rivolta d'Adda 26026, Italy

GSK Clinical Trials - Call centre, Cassano Murge 70020, Italy

GSK Clinical Trials - Call centre, San Sisto 06132, Italy

GSK Clinical Trials - Call centre, Genova 16132, Italy

GSK Clinical Trials - Call centre, Eboli (SA) 84025, Italy

GSK Clinical Trials - Call centre, Milano 20142, Italy

GSK Clinical Trials - Call centre, Milano 20132, Italy

GSK Clinical Trials - Call centre, Napoli 80131, Italy

GSK Clinical Trials - Call centre, Riga LV-1002, Latvia

GSK Clinical Trials - Call centre, Riga LV-1035, Latvia

GSK Clinical Trials - Call centre, Jekabpils LV-5201, Latvia

GSK Clinical Trials - Call centre, Riga LV-1079, Latvia

GSK Clinical Trials - Call centre, Klaipeda LT-92288, Lithuania

GSK Clinical Trials - Call centre, Alytus LT-62114, Lithuania

GSK Clinical Trials - Call centre, Kaunas LT-50009, Lithuania

GSK Clinical Trials - Call centre, Vilnius LT-07156, Lithuania

GSK Clinical Trials - Call centre, Klaipeda LT-92231, Lithuania

GSK Clinical Trials - Call centre, Breda 4819 EV, Netherlands

GSK Clinical Trials - Call centre, Eindhoven 5623 EJ, Netherlands

GSK Clinical Trials - Call centre, Almere 1315 RA, Netherlands

GSK Clinical Trials - Call centre, Leiderdorp 2353 GA, Netherlands

GSK Clinical Trials - Call centre, Arnhem 6815 AD, Netherlands

GSK Clinical Trials - Call centre, Sneek 8601 ZK, Netherlands

GSK Clinical Trials - Call centre, Harderwijk 3844 DG, Netherlands

GSK Clinical Trials - Call centre, Oss 5342 BT, Netherlands

GSK Clinical Trials - Call centre, Venlo 5912 BL, Netherlands

GSK Clinical Trials - Call centre, Meppel 7943 KA, Netherlands

GSK Clinical Trials - Call centre, Amsterdam 1091 AC, Netherlands

GSK Clinical Trials - Call centre, Amsterdam 1105 AZ, Netherlands

GSK Clinical Trials - Call centre, Zwolle 8025 AB, Netherlands

GSK Clinical Trials - Call centre, Veldhoven 5504 DB, Netherlands

GSK Clinical Trials - Call centre, Hertogenbosch 5211 NL, Netherlands

GSK Clinical Trials - Call centre, Weert 6001 BE, Netherlands

GSK Clinical Trials - Call centre, Almelo 7609 PP, Netherlands

GSK Clinical Trials - Call centre, Amersfoort 3818 ES, Netherlands

GSK Clinical Trials - Call centre, Hoorn 1624 NP, Netherlands

GSK Clinical Trials - Call centre, Amsterdam 1034 CS, Netherlands

GSK Clinical Trials - Call centre, Fredrikstad 1606, Norway

GSK Clinical Trials - Call centre, Gjettum 1346, Norway

GSK Clinical Trials - Call centre, Trondheim 7030, Norway

GSK Clinical Trials - Call centre, Tonsberg 3116, Norway

GSK Clinical Trials - Call centre, Kristiansand 4615, Norway

GSK Clinical Trials - Call centre, Moelv 2391, Norway

GSK Clinical Trials - Call centre, Bergen 5021, Norway

GSK Clinical Trials - Call centre, Oslo 0855, Norway

GSK Clinical Trials - Call centre, Oslo 1150, Norway

GSK Clinical Trials - Call centre, Trondheim 7027, Norway

GSK Clinical Trials - Call centre, Volda 6100, Norway

GSK Clinical Trials - Call centre, Iasi 700115, Romania

GSK Clinical Trials - Call centre, Deva 330021, Romania

GSK Clinical Trials - Call centre, Cluj-Napoca 400371, Romania

GSK Clinical Trials - Call centre, Bucharest 060338, Romania

GSK Clinical Trials - Call centre, Bucuresti 010457, Romania

GSK Clinical Trials - Call centre, Bucharest 050159, Romania

GSK Clinical Trials - Call centre, Irkutsk 664005, Russian Federation

GSK Clinical Trials - Call centre, Moscow 105 077, Russian Federation

GSK Clinical Trials - Call centre, St. Petersburg 197 089, Russian Federation

GSK Clinical Trials - Call centre, Moscow 119 881, Russian Federation

GSK Clinical Trials - Call centre, Moscow 105 229, Russian Federation

GSK Clinical Trials - Call centre, Moscow 109 240, Russian Federation

GSK Clinical Trials - Call centre, Cadca 02216, Slovakia

GSK Clinical Trials - Call centre, Kosice 04001, Slovakia

GSK Clinical Trials - Call centre, Prievidza 97101, Slovakia

GSK Clinical Trials - Call centre, Bratislava 85101, Slovakia

GSK Clinical Trials - Call centre, Bardejov 08501, Slovakia

GSK Clinical Trials - Call centre, Bratislava 84104, Slovakia

GSK Clinical Trials - Call centre, Litija 1270, Slovenia

GSK Clinical Trials - Call centre, Golnik 4204, Slovenia

GSK Clinical Trials - Call centre, Topolsica 3326, Slovenia

GSK Clinical Trials - Call centre, Hoce 2311, Slovenia

GSK Clinical Trials - Call centre, Madrid 28046, Spain

GSK Clinical Trials - Call centre, Santiago de Compostela 15706, Spain

GSK Clinical Trials - Call centre, Madrid 28041, Spain

GSK Clinical Trials - Call centre, Zaragoza 50009, Spain

GSK Clinical Trials - Call centre, Guadalajara 19002, Spain

GSK Clinical Trials - Call centre, Figueres 17600, Spain

GSK Clinical Trials - Call centre, Barcelona 08035, Spain

GSK Clinical Trials - Call centre, Valencia 46014, Spain

GSK Clinical Trials - Call centre, Karlstad SE-651 85, Sweden

GSK Clinical Trials - Call centre, Linkoping SE-581 85, Sweden

GSK Clinical Trials - Call centre, Boden SE-961 64, Sweden

GSK Clinical Trials - Call centre, Uppsala SE-751 85, Sweden

GSK Clinical Trials - Call centre, Orebro SE-701 85, Sweden

GSK Clinical Trials - Call centre, Stockholm SE-171 76, Sweden

GSK Clinical Trials - Call centre, Eksjo SE-575 81, Sweden

GSK Clinical Trials - Call centre, Stockholm SE-141 86, Sweden

GSK Clinical Trials - Call centre, Malmo SE-205 02, Sweden

GSK Clinical Trials - Call centre, Kiev 3680, Ukraine

GSK Clinical Trials - Call centre, Kiev 0411 2, Ukraine

GSK Clinical Trials - Call centre, Newcastle-Upon-Tyne NE7 7DN, United Kingdom

GSK Clinical Trials - Call centre, Peterborough PE3 6DA, United Kingdom

GSK Clinical Trials - Call centre, Edinburgh EH16 4SA, United Kingdom

GSK Clinical Trials - Call centre, Newcastle-Upon-Tyne NE4 6BE, United Kingdom

GSK Clinical Trials - Call centre, Glasgow G31 1ER, United Kingdom

GSK Clinical Trials - Call centre, Birmingham B15 2TH, United Kingdom

GSK Clinical Trials - Call centre, London E2 9JX, United Kingdom

GSK Clinical Trials - Call centre, Isleworth TW7 6AG, United Kingdom

GSK Clinical Trials - Call centre, San Vicente de Raspeig, Alicante 03690, Spain

GSK Clinical Trials - Call centre, Orihuela, Alicante 03314, Spain

GSK Clinical Trials - Call centre, Weinheim, Baden-Wurttemberg 69469, Germany

GSK Clinical Trials - Call centre, Tarrasa, Barcelona 08221, Spain

GSK Clinical Trials - Call centre, Vic, Barcelona 08500, Spain

GSK Clinical Trials - Call centre, Muenchen, Bayern 80335, Germany

GSK Clinical Trials - Call centre, Muenchen, Bayern 81677, Germany

GSK Clinical Trials - Call centre, Erlangen, Bayern 91052, Germany

GSK Clinical Trials - Call centre, Bad Toelz, Bayern 83646, Germany

GSK Clinical Trials - Call centre, Bad Woerrishofen, Bayern 86825, Germany

GSK Clinical Trials - Call centre, Augsburg, Bayern 86156, Germany

GSK Clinical Trials - Call centre, Chania, Crete 73300, Greece

GSK Clinical Trials - Call centre, Rethymnon, Crete 74100, Greece

GSK Clinical Trials - Call centre, Heraklion, Crete 71409, Greece

GSK Clinical Trials - Call centre, Kassel, Hessen 34121, Germany

GSK Clinical Trials - Call centre, Kassel, Hessen 34117, Germany

GSK Clinical Trials - Call centre, Eschwege, Hessen 37269, Germany

GSK Clinical Trials - Call centre, Gelnhausen, Hessen 63571, Germany

GSK Clinical Trials - Call centre, Marburg, Hessen 35037, Germany

GSK Clinical Trials - Call centre, Liverpool, Lancashire L9 7AL, United Kingdom

GSK Clinical Trials - Call centre, Manchester, Lancashire M8 5RB, United Kingdom

GSK Clinical Trials - Call centre, Bielefeld, Nordrhein-Westfalen 33602, Germany

GSK Clinical Trials - Call centre, Galdakano, Vizcaya 48960, Spain

GSK Clinical Trials - Call centre, Barakaldo, Vizcaya 48903, Spain

Starting date: September 2003
Last updated: August 7, 2006