SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease
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 Delivered Twice Daily Via the DISKUS*/ACCUHALER* Inhaler With Tiotropium Bromide 18 mcg Delivered Once Daily Via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
1,270
18 countries
155
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2003
Typical duration for phase_4
155 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 7, 2006
CompletedFirst Posted
Study publicly available on registry
August 9, 2006
CompletedJanuary 20, 2017
January 1, 2017
2.7 years
August 7, 2006
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of healthcare utilisation based exacerbations of COPD
Secondary Outcomes (1)
Rates for exacerbations based on symptoms, treatment with oral corticosteroids and for antibioticsTime to next exacerbation, duration and difference between healthcare utilisation and symptom based exacerbation
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (166)
GSK Investigational Site
Grimmenstein, A-2840, Austria
GSK Investigational Site
Mödling, A-2340, Austria
GSK Investigational Site
Salzburg, A-5020, Austria
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Vienna, A-1120, Austria
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Brussels, 1000, Belgium
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Brussels, 1020, Belgium
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Edegem, 2650, Belgium
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Genk, 3600, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Blansko, 678 31, Czechia
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Kyjov, 697 33, Czechia
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Olomouc, 775 25, Czechia
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Ostrava, 703 00, Czechia
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Pilsen, 301 00, Czechia
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Pilsen, 326 00, Czechia
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Prague, 140 46, Czechia
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Prague, 180 81, Czechia
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Aalborg, DK-9100, Denmark
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Aarhus C, DK-8000, Denmark
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København NV, 2400, Denmark
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Odense C, DK-5000, Denmark
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Paide, 72712, Estonia
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Pärnu, 80024, Estonia
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Tallinn, 1162, Estonia
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Tallinn, 13619, Estonia
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Tallinn, Estonia
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Tartu, 51014, Estonia
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Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site
Augsburg, Bavaria, 86156, Germany
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Bad Kissingen, Bavaria, 97688, Germany
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Bad Tölz, Bavaria, 83646, Germany
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Bad Woerrishofen, Bavaria, 86825, Germany
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Erlangen, Bavaria, 91052, Germany
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Munich, Bavaria, 80335, Germany
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Munich, Bavaria, 81677, Germany
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Eschwege, Hesse, 37269, Germany
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Gelnhausen, Hesse, 63571, Germany
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Kassel, Hesse, 34117, Germany
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Kassel, Hesse, 34121, Germany
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Marburg, Hesse, 35037, Germany
GSK Investigational Site
Bielefeld, North Rhine-Westphalia, 33602, Germany
GSK Investigational Site
Berlin, State of Berlin, 10178, Germany
GSK Investigational Site
Berlin, State of Berlin, 10367, Germany
GSK Investigational Site
Berlin, State of Berlin, 10559, Germany
GSK Investigational Site
Berlin, State of Berlin, 10585, Germany
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Berlin, State of Berlin, 10965, Germany
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Athens, 15669, Greece
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Athens, 184 54, Greece
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Chania, Crete, 73300, Greece
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Heraklion, Crete, 71409, Greece
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Kavala, Greece
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Periohi Dragana, Alexandroupolis, 68100, Greece
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Rethymnon, Crete, 74100, Greece
GSK Investigational Site
Cassano Murge (BA), Apulia, 70020, Italy
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Foggia, Apulia, 71100, Italy
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Eboli (SA), Campania, 84025, Italy
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Napoli, Campania, 80131, Italy
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Salerno, Campania, 84126, Italy
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Telese (BN), Campania, 82037, Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100, Italy
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Genoa, Liguria, 16132, Italy
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Milan, Lombardy, 20132, Italy
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Milan, Lombardy, 20142, Italy
GSK Investigational Site
Rivolta d'Adda (CR), Lombardy, 26026, Italy
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Sesto San Giovanni (MI), Lombardy, 20099, Italy
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Ascoli Piceno, The Marches, 63100, Italy
GSK Investigational Site
Pisa, Tuscany, 56124, Italy
GSK Investigational Site
San Sisto (PG), Umbria, 06132, Italy
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Padua, Veneto, 35128, Italy
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Jēkabpils, LV 5201, Latvia
GSK Investigational Site
Riga, LV 1002, Latvia
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Riga, LV 1035, Latvia
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Riga, LV1079, Latvia
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Alytus, LT-62114, Lithuania
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Kaunas, LT-50009, Lithuania
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Klaipėda, LT-92231, Lithuania
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Klaipėda, LT-92288, Lithuania
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Vilnius, LT-07156, Lithuania
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's-Hertogenbosch, 5211 NL, Netherlands
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Almelo, 7609 PP, Netherlands
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Almere Stad, 1315 RA, Netherlands
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Amersfoort, 3818 ES, Netherlands
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Amsterdam, 1034 CS, Netherlands
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Amsterdam, 1091 AC, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Arnhem, 6815 AD, Netherlands
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Breda, 4819 EV, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Harderwijk, 3844 DG, Netherlands
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Hoorn, 1624 NP, Netherlands
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Leiderdorp, 2353 GA, Netherlands
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Meppel, 7943 KA, Netherlands
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Oss, 5342 BT, Netherlands
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Sneek, 8601 ZK, Netherlands
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Veldhoven, 5504 DB, Netherlands
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Venlo, 5912 BL, Netherlands
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Weert, 6001 BE, Netherlands
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Zwolle, 8025 AB, Netherlands
GSK Investigational Site
Bergen, 5053, Norway
GSK Investigational Site
Egsjordet, Norway
GSK Investigational Site
Fredrikstad, 1606, Norway
GSK Investigational Site
Gjettum, N-1346, Norway
GSK Investigational Site
Moelv, 2391, Norway
GSK Investigational Site
Oslo, 1150, Norway
GSK Investigational Site
Oslo, 855, Norway
GSK Investigational Site
Trondheim, N-7027, Norway
GSK Investigational Site
Trondheim, N-7030, Norway
GSK Investigational Site
Tønsberg, N-3117, Norway
GSK Investigational Site
Volda, 6100, Norway
GSK Investigational Site
Bucharest, 020125, Romania
GSK Investigational Site
Bucharest, 050159, Romania
GSK Investigational Site
Bucharest, 70000, Romania
GSK Investigational Site
Cluj-Napoca, 400371, Romania
GSK Investigational Site
Deva, 2700, Romania
GSK Investigational Site
Iași, 700115, Romania
GSK Investigational Site
Irkutsk, 664005, Russia
GSK Investigational Site
Moscow, 105 077, Russia
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Moscow, 105 229, Russia
GSK Investigational Site
Moscow, 109240, Russia
GSK Investigational Site
Moscow, 119 881, Russia
GSK Investigational Site
Saint Petersburg, 197 089, Russia
GSK Investigational Site
Bardejov, 085 01, Slovakia
GSK Investigational Site
Bratislava, 811 01, Slovakia
GSK Investigational Site
Bratislava, 833 40, Slovakia
GSK Investigational Site
Košice, 040 01, Slovakia
GSK Investigational Site
Prievidza, 971 01, Slovakia
GSK Investigational Site
Golnik, 4204, Slovenia
GSK Investigational Site
Litija, 1270, Slovenia
GSK Investigational Site
Topolšica, 3326, Slovenia
GSK Investigational Site
Zgornje Hoče, 2311, Slovenia
GSK Investigational Site
Alicante, Spain
GSK Investigational Site
Barakaldo (Vizcaya), 48903, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08221, Spain
GSK Investigational Site
Figueres, Spain
GSK Investigational Site
Galdakano, 48960, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28047, Spain
GSK Investigational Site
Orihuela (Alicante), Spain
GSK Investigational Site
Vic, 28500, Spain
GSK Investigational Site
Zaragoza, 50009, Spain
GSK Investigational Site
Eksjö, SE-575 81, Sweden
GSK Investigational Site
Karlstad, SE-651 85, Sweden
GSK Investigational Site
Linköping, SE-581 85, Sweden
GSK Investigational Site
Luleå, SE-971 89, Sweden
GSK Investigational Site
Malmo, SE-205 02, Sweden
GSK Investigational Site
Örebro, SE-701 85, Sweden
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Stockholm, SE-141 86, Sweden
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Stockholm, SE-171 76, Sweden
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Uppsala, SE-751 85, Sweden
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Kiev, 03680, Ukraine
GSK Investigational Site
Kiev, 3680, Ukraine
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Kyiv, Ukraine
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Peterborough, Cambridgeshire, PE3 6DA, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, G4 0SF, United Kingdom
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Liverpool, Lancashire, L9 7AL, United Kingdom
GSK Investigational Site
Manchester, Lancashire, M8 5RB, United Kingdom
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Isleworth, Middlesex, TW7 6AG, United Kingdom
GSK Investigational Site
Edinburgh, Midlothian, EH3 9YW, United Kingdom
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Newcastle upon Tyne, Northumberland, NE1 4LP, United Kingdom
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Newcastle upon Tyne, Northumberland, NE7 7DN, United Kingdom
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Birmingham, Warwickshire, B15 2TH, United Kingdom
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London, E2 9JX, United Kingdom
GSK Investigational Site
Related Publications (6)
Calverley PMA, Stockley RA, Seemungal TAR, Hagan G, Willits LR, Riley JH, Wedzicha JA; Investigating New Standards for Prophylaxis in Reduction of Exacerbations (INSPIRE) Investigators. Reported pneumonia in patients with COPD: findings from the INSPIRE study. Chest. 2011 Mar;139(3):505-512. doi: 10.1378/chest.09-2992. Epub 2010 Jun 24.
PMID: 20576732BACKGROUNDChui D, Tejani AM. The INSPIRE trial results: are they truly breathtaking? Am J Respir Crit Care Med. 2009 Jan 1;179(1):80; author reply 80-1. doi: 10.1164/ajrccm.179.1.80. No abstract available.
PMID: 19098157BACKGROUNDHilleman DE, Malesker MA, Morrow LE, Schuller D. A systematic review of the cardiovascular risk of inhaled anticholinergics in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:253-63. doi: 10.2147/copd.s4620. Epub 2009 Jul 20.
PMID: 19657399BACKGROUNDLanes SF, Jara M. The INSPIRE study: influence of prior use and discontinuation of inhaled corticosteroids. Am J Respir Crit Care Med. 2008 Sep 1;178(5):543-4; author reply 544. doi: 10.1164/ajrccm.178.5.543. No abstract available.
PMID: 18713851BACKGROUNDMiddleton PG. Management of patients with COPD: a comparison of the INSPIRE and TORCH studies. Am J Respir Crit Care Med. 2008 Jul 1;178(1):106; author reply 106-7. doi: 10.1164/ajrccm.178.1.106. No abstract available.
PMID: 18565964BACKGROUNDWedzicha JA, Calverley PM, Seemungal TA, Hagan G, Ansari Z, Stockley RA; INSPIRE Investigators. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med. 2008 Jan 1;177(1):19-26. doi: 10.1164/rccm.200707-973OC. Epub 2007 Oct 4.
PMID: 17916806BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2006
First Posted
August 9, 2006
Study Start
June 1, 2003
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
January 20, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.