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

NCT ID: NCT00361959

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2006-02-28

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.

Detailed Description

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)

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Tiotropium bromide 18mcg

Intervention Type: DRUG

Fluticasone propionate/ salmeterol combination 50/500mcg

Intervention Type: DRUG

Other Intervention Names

Tiotropium bromide 18mcg

Eligibility 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Grimmenstein, , Austria

GSK Investigational Site

Mödling, , Austria

GSK Investigational Site

Salzburg, , Austria

GSK Investigational Site

Vienna, , Austria

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Edegem, , Belgium

GSK Investigational Site

Genk, , Belgium

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Liège, , Belgium

GSK Investigational Site

Blansko, , Czechia

GSK Investigational Site

Kyjov, , Czechia

GSK Investigational Site

Olomouc, , Czechia

GSK Investigational Site

Ostrava, , Czechia

GSK Investigational Site

Pilsen, , Czechia

GSK Investigational Site

Pilsen, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Aalborg, , Denmark

GSK Investigational Site

Aarhus C, , Denmark

GSK Investigational Site

København NV, , Denmark

GSK Investigational Site

Odense C, , Denmark

GSK Investigational Site

Paide, , Estonia

GSK Investigational Site

Pärnu, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Augsburg, Bavaria, Germany

GSK Investigational Site

Bad Kissingen, Bavaria, Germany

GSK Investigational Site

Bad Tölz, Bavaria, Germany

GSK Investigational Site

Bad Woerrishofen, Bavaria, Germany

GSK Investigational Site

Erlangen, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Eschwege, Hesse, Germany

GSK Investigational Site

Gelnhausen, Hesse, Germany

GSK Investigational Site

Kassel, Hesse, Germany

GSK Investigational Site

Kassel, Hesse, Germany

GSK Investigational Site

Marburg, Hesse, Germany

GSK Investigational Site

Bielefeld, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Chania, Crete, , Greece

GSK Investigational Site

Heraklion, Crete, , Greece

GSK Investigational Site

Kavala, , Greece

GSK Investigational Site

Periohi Dragana, Alexandroupolis, , Greece

GSK Investigational Site

Rethymnon, Crete, , Greece

GSK Investigational Site

Cassano Murge (BA), Apulia, Italy

GSK Investigational Site

Foggia, Apulia, Italy

GSK Investigational Site

Eboli (SA), Campania, Italy

GSK Investigational Site

Napoli, Campania, Italy

GSK Investigational Site

Salerno, Campania, Italy

GSK Investigational Site

Telese (BN), Campania, Italy

GSK Investigational Site

Ferrara, Emilia-Romagna, Italy

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Rivolta d'Adda (CR), Lombardy, Italy

GSK Investigational Site

Sesto San Giovanni (MI), Lombardy, Italy

GSK Investigational Site

Ascoli Piceno, The Marches, Italy

GSK Investigational Site

Pisa, Tuscany, Italy

GSK Investigational Site

San Sisto (PG), Umbria, Italy

GSK Investigational Site

Padua, Veneto, Italy

GSK Investigational Site

Jēkabpils, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Alytus, , Lithuania

GSK Investigational Site

Kaunas, , Lithuania

GSK Investigational Site

Klaipėda, , Lithuania

GSK Investigational Site

Klaipėda, , Lithuania

GSK Investigational Site

Vilnius, , Lithuania

GSK Investigational Site

's-Hertogenbosch, , Netherlands

GSK Investigational Site

Almelo, , Netherlands

GSK Investigational Site

Almere Stad, , Netherlands

GSK Investigational Site

Amersfoort, , Netherlands

GSK Investigational Site

Amsterdam, , Netherlands

GSK Investigational Site

Amsterdam, , Netherlands

GSK Investigational Site

Amsterdam, , Netherlands

GSK Investigational Site

Arnhem, , Netherlands

GSK Investigational Site

Breda, , Netherlands

GSK Investigational Site

Eindhoven, , Netherlands

GSK Investigational Site

Harderwijk, , Netherlands

GSK Investigational Site

Hoorn, , Netherlands

GSK Investigational Site

Leiderdorp, , Netherlands

GSK Investigational Site

Meppel, , Netherlands

GSK Investigational Site

Oss, , Netherlands

GSK Investigational Site

Sneek, , Netherlands

GSK Investigational Site

Veldhoven, , Netherlands

GSK Investigational Site

Venlo, , Netherlands

GSK Investigational Site

Weert, , Netherlands

GSK Investigational Site

Zwolle, , Netherlands

GSK Investigational Site

Bergen, , Norway

GSK Investigational Site

Egsjordet, , Norway

GSK Investigational Site

Fredrikstad, , Norway

GSK Investigational Site

Gjettum, , Norway

GSK Investigational Site

Moelv, , Norway

GSK Investigational Site

Oslo, , Norway

GSK Investigational Site

Oslo, , Norway

GSK Investigational Site

Trondheim, , Norway

GSK Investigational Site

Trondheim, , Norway

GSK Investigational Site

Tønsberg, , Norway

GSK Investigational Site

Volda, , Norway

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Cluj-Napoca, , Romania

GSK Investigational Site

Deva, , Romania

GSK Investigational Site

Iași, , Romania

GSK Investigational Site

Irkutsk, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Bardejov, , Slovakia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Košice, , Slovakia

GSK Investigational Site

Prievidza, , Slovakia

GSK Investigational Site

Golnik, , Slovenia

GSK Investigational Site

Litija, , Slovenia

GSK Investigational Site

Topolšica, , Slovenia

GSK Investigational Site

Zgornje Hoče, , Slovenia

GSK Investigational Site

Alicante, , Spain

GSK Investigational Site

Barakaldo (Vizcaya), , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Figueres, , Spain

GSK Investigational Site

Galdakano, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Orihuela (Alicante), , Spain

GSK Investigational Site

Vic, , Spain

GSK Investigational Site

Zaragoza, , Spain

GSK Investigational Site

Eksjö, , Sweden

GSK Investigational Site

Karlstad, , Sweden

GSK Investigational Site

Linköping, , Sweden

GSK Investigational Site

Luleå, , Sweden

GSK Investigational Site

Malmo, , Sweden

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Stockholm, , Sweden

GSK Investigational Site

Stockholm, , Sweden

GSK Investigational Site

Uppsala, , Sweden

GSK Investigational Site

Kiev, , Ukraine

GSK Investigational Site

Kiev, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Peterborough, Cambridgeshire, United Kingdom

GSK Investigational Site

Glasgow, Lanarkshire, United Kingdom

GSK Investigational Site

Liverpool, Lancashire, United Kingdom

GSK Investigational Site

Manchester, Lancashire, United Kingdom

GSK Investigational Site

Isleworth, Middlesex, United Kingdom

GSK Investigational Site

Edinburgh, Midlothian, United Kingdom

GSK Investigational Site

Newcastle upon Tyne, Northumberland, United Kingdom

GSK Investigational Site

Newcastle upon Tyne, Northumberland, United Kingdom

GSK Investigational Site

Birmingham, Warwickshire, United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

, ,

Countries

Austria; Belgium; Czechia; Denmark; Estonia; Germany; Greece; Italy; Latvia; Lithuania; Netherlands; Norway; Romania; Russia; Slovakia; Slovenia; Spain; Sweden; Ukraine; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 20576732 (View on PubMed)

Chui 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.

Reference Type: BACKGROUND

PMID: 19098157 (View on PubMed)

Hilleman 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.

Reference Type: BACKGROUND

PMID: 19657399 (View on PubMed)

Lanes 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.

Reference Type: BACKGROUND

PMID: 18713851 (View on PubMed)

Middleton 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.

Reference Type: BACKGROUND

PMID: 18565964 (View on PubMed)

Wedzicha 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.

Reference Type: BACKGROUND

PMID: 17916806 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

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Related Links

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Other Identifiers

SCO40036

Identifier Type: -

Identifier Source: org_study_id