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Pulmonary Disease, Chronic ObstructivePhase 4NCT00361959

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

A Phase 4 study testing Tiotropium bromide 18mcg and Fluticasone propionate/ salmeterol combination 50/500mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 166 sites in 21 countries.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Tiotropium bromide 18mcg and Fluticasone propionate/ salmeterol combination 50/500mcg
How many people
1,270 participants
Where
166 sitesin 21 countries
Study dates
Jun 2003to Feb 2006
Phase
Phase 4
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 11Show fewer
  • 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).

Trial locations and contacts

166 sites in 21 countries.

166 sites in 21 countries

Netherlands20 sites

  • GSK Investigational Site

    's-Hertogenbosch, 5211 NL

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Almere Stad, 1315 RA

  • GSK Investigational Site

    Amersfoort, 3818 ES

  • GSK Investigational Site

    Amsterdam, 1034 CS

  • GSK Investigational Site

    Amsterdam, 1091 AC

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Arnhem, 6815 AD

  • GSK Investigational Site

    Breda, 4819 EV

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Harderwijk, 3844 DG

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    Leiderdorp, 2353 GA

  • GSK Investigational Site

    Meppel, 7943 KA

  • GSK Investigational Site

    Oss, 5342 BT

  • GSK Investigational Site

    Sneek, 8601 ZK

  • GSK Investigational Site

    Veldhoven, 5504 DB

  • GSK Investigational Site

    Venlo, 5912 BL

  • GSK Investigational Site

    Weert, 6001 BE

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Germany19 sites

  • GSK Investigational Site

    Augsburg, Bavaria, 86156

  • GSK Investigational Site

    Bad Kissingen, Bavaria, 97688

  • GSK Investigational Site

    Bad Tölz, Bavaria, 83646

  • GSK Investigational Site

    Bad Woerrishofen, Bavaria, 86825

  • GSK Investigational Site

    Berlin, State of Berlin, 10178

  • GSK Investigational Site

    Berlin, State of Berlin, 10367

  • GSK Investigational Site

    Berlin, State of Berlin, 10559

  • GSK Investigational Site

    Berlin, State of Berlin, 10585

  • GSK Investigational Site

    Berlin, State of Berlin, 10965

  • GSK Investigational Site

    Bielefeld, North Rhine-Westphalia, 33602

  • GSK Investigational Site

    Erlangen, Bavaria, 91052

  • GSK Investigational Site

    Eschwege, Hesse, 37269

  • GSK Investigational Site

    Gelnhausen, Hesse, 63571

  • GSK Investigational Site

    Kassel, Hesse, 34117

  • GSK Investigational Site

    Kassel, Hesse, 34121

  • GSK Investigational Site

    Marburg, Hesse, 35037

  • GSK Investigational Site

    Munich, Bavaria, 80335

  • GSK Investigational Site

    Munich, Bavaria, 81677

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 69469

Other trials in Germany

Italy16 sites

  • GSK Investigational Site

    Ascoli Piceno, The Marches, 63100

  • GSK Investigational Site

    Cassano Murge (BA), Apulia, 70020

  • GSK Investigational Site

    Eboli (SA), Campania, 84025

  • GSK Investigational Site

    Ferrara, Emilia-Romagna, 44100

  • GSK Investigational Site

    Foggia, Apulia, 71100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Milan, Lombardy, 20142

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Rivolta d'Adda (CR), Lombardy, 26026

  • GSK Investigational Site

    Salerno, Campania, 84126

  • GSK Investigational Site

    San Sisto (PG), Umbria, 06132

  • GSK Investigational Site

    Sesto San Giovanni (MI), Lombardy, 20099

  • GSK Investigational Site

    Telese (BN), Campania, 82037

Other trials in Italy

Norway11 sites

  • GSK Investigational Site

    Bergen, 5053

  • GSK Investigational Site

    Egsjordet

  • GSK Investigational Site

    Fredrikstad, 1606

  • GSK Investigational Site

    Gjettum, N-1346

  • GSK Investigational Site

    Moelv, 2391

  • GSK Investigational Site

    Oslo, 1150

  • GSK Investigational Site

    Oslo, 855

  • GSK Investigational Site

    Tønsberg, N-3117

  • GSK Investigational Site

    Trondheim, N-7027

  • GSK Investigational Site

    Trondheim, N-7030

  • GSK Investigational Site

    Volda, 6100

Other trials in Norway

Spain11 sites

  • GSK Investigational Site

    Alicante

  • GSK Investigational Site

    Barakaldo (Vizcaya), 48903

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08221

  • GSK Investigational Site

    Figueres

  • GSK Investigational Site

    Galdakano, 48960

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28047

  • GSK Investigational Site

    Orihuela (Alicante)

  • GSK Investigational Site

    Vic, 28500

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

United Kingdom10 sites

  • GSK Investigational Site

    Birmingham, Warwickshire, B15 2TH

  • GSK Investigational Site

    Edinburgh, Midlothian, EH3 9YW

  • GSK Investigational Site

    Glasgow, Lanarkshire, G4 0SF

  • GSK Investigational Site

    Isleworth, Middlesex, TW7 6AG

  • GSK Investigational Site

    Liverpool, Lancashire, L9 7AL

  • GSK Investigational Site

    London, E2 9JX

  • GSK Investigational Site

    Manchester, Lancashire, M8 5RB

  • GSK Investigational Site

    Newcastle upon Tyne, Northumberland, NE1 4LP

  • GSK Investigational Site

    Newcastle upon Tyne, Northumberland, NE7 7DN

  • GSK Investigational Site

    Peterborough, Cambridgeshire, PE3 6DA

Other trials in United Kingdom

Sweden9 sites

  • GSK Investigational Site

    Eksjö, SE-575 81

  • GSK Investigational Site

    Karlstad, SE-651 85

  • GSK Investigational Site

    Linköping, SE-581 85

  • GSK Investigational Site

    Luleå, SE-971 89

  • GSK Investigational Site

    Malmö, SE-205 02

  • GSK Investigational Site

    Örebro, SE-701 85

  • GSK Investigational Site

    Stockholm, SE-141 86

  • GSK Investigational Site

    Stockholm, SE-171 76

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Czechia8 sites

  • GSK Investigational Site

    Blansko, 678 31

  • GSK Investigational Site

    Kyjov, 697 33

  • GSK Investigational Site

    Olomouc, 775 25

  • GSK Investigational Site

    Ostrava, 703 00

  • GSK Investigational Site

    Pilsen, 301 00

  • GSK Investigational Site

    Pilsen, 326 00

  • GSK Investigational Site

    Prague, 140 46

  • GSK Investigational Site

    Prague, 180 81

Other trials in Czechia

Belgium7 sites

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Brussels, 1020

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

Other trials in Belgium

Greece7 sites

  • GSK Investigational Site

    Athens, 15669

  • GSK Investigational Site

    Athens, 184 54

  • GSK Investigational Site

    Chania, Crete, 73300

  • GSK Investigational Site

    Heraklion, Crete, 71409

  • GSK Investigational Site

    Kavala

  • GSK Investigational Site

    Periohi Dragana, Alexandroupolis, 68100

  • GSK Investigational Site

    Rethymnon, Crete, 74100

Other trials in Greece

Estonia6 sites

  • GSK Investigational Site

    Paide, 72712

  • GSK Investigational Site

    Pärnu, 80024

  • GSK Investigational Site

    Tallinn, 1162

  • GSK Investigational Site

    Tallinn, 13619

  • GSK Investigational Site

    Tallinn

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Romania6 sites

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Bucharest, 70000

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Deva, 2700

  • GSK Investigational Site

    Iași, 700115

Other trials in Romania

Russia6 sites

  • GSK Investigational Site

    Irkutsk, 664005

  • GSK Investigational Site

    Moscow, 105 077

  • GSK Investigational Site

    Moscow, 105 229

  • GSK Investigational Site

    Moscow, 109240

  • GSK Investigational Site

    Moscow, 119 881

  • GSK Investigational Site

    Saint Petersburg, 197 089

Other trials in Russia

Lithuania5 sites

  • GSK Investigational Site

    Alytus, LT-62114

  • GSK Investigational Site

    Kaunas, LT-50009

  • GSK Investigational Site

    Klaipėda, LT-92231

  • GSK Investigational Site

    Klaipėda, LT-92288

  • GSK Investigational Site

    Vilnius, LT-07156

Other trials in Lithuania

Slovakia5 sites

  • GSK Investigational Site

    Bardejov, 085 01

  • GSK Investigational Site

    Bratislava, 811 01

  • GSK Investigational Site

    Bratislava, 833 40

  • GSK Investigational Site

    Košice, 040 01

  • GSK Investigational Site

    Prievidza, 971 01

Other trials in Slovakia

Austria4 sites

  • GSK Investigational Site

    Grimmenstein, A-2840

  • GSK Investigational Site

    Mödling, A-2340

  • GSK Investigational Site

    Salzburg, A-5020

  • GSK Investigational Site

    Vienna, A-1120

Other trials in Austria

Denmark4 sites

  • GSK Investigational Site

    Aalborg, DK-9100

  • GSK Investigational Site

    Aarhus C, DK-8000

  • GSK Investigational Site

    København NV, 2400

  • GSK Investigational Site

    Odense C, DK-5000

Other trials in Denmark

Latvia4 sites

  • GSK Investigational Site

    Jēkabpils, LV 5201

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Riga, LV 1035

  • GSK Investigational Site

    Riga, LV1079

Other trials in Latvia

Slovenia4 sites

  • GSK Investigational Site

    Golnik, 4204

  • GSK Investigational Site

    Litija, 1270

  • GSK Investigational Site

    Topolšica, 3326

  • GSK Investigational Site

    Zgornje Hoče, 2311

Other trials in Slovenia

Ukraine3 sites

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kiev, 3680

  • GSK Investigational Site

    Kyiv

Other trials in Ukraine

Location not given1 site

  • GSK Investigational Site

About this study

Official title: 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)

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.

Read the 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)

Being tested
Tiotropium bromide 18mcg, Fluticasone propionate/ salmeterol combination 50/500mcg
Keywords
fluticasone propionate/salmeterol combination, tiotropium, SERETIDE, COPD exacerbation
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.

  • Tiotropium bromide 18mcgDrug

  • Fluticasone propionate/ salmeterol combination 50/500mcgDrug

    Also called Tiotropium bromide 18mcg

What is being measured

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

  1. Rate of healthcare utilisation based exacerbations of COPD

Secondary outcomes (1)

  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

Timeline

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

  1. First posted9 Aug 2006 (estimated)
  2. Study startJun 2003
  3. Primary completionFeb 2006
  4. Study completionFeb 2006

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00361959
Sponsor's protocol ID
SCO40036
Status last verified
Jan 2017
First submitted
7 Aug 2006
Last updated
20 Jan 2017
Results posted
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 20576732

  • 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.

    PubMed 19098157

  • 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.

    PubMed 19657399

  • 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.

    PubMed 18713851

  • 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.

    PubMed 18565964

  • 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.

    PubMed 17916806

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tiotropium bromide 18mcg and Fluticasone propionate/ salmeterol combination 50/500mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 166 sites in 21 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 6 inclusion and 11 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in Netherlands, Germany, Italy, Norway, Spain and 15 more countries. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of healthcare utilisation based exacerbations of COPD. 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 NCT00361959, which also lists 6 linked publications.

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 20 Jan 2017.

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