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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tiotropium bromide 18mcg
Fluticasone propionate/ salmeterol combination 50/500mcg
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring fluticasone propionate/salmeterol combination, tiotropium, SERETIDE, COPD exacerbation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • GSK Investigational Site
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Outcomes

Primary Outcome Measures

Rate of healthcare utilisation based exacerbations of COPD

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2006
Last Updated
January 19, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00361959
Brief Title
SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2003 (Actual)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
fluticasone propionate/salmeterol combination, tiotropium, SERETIDE, COPD exacerbation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1270 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tiotropium bromide 18mcg
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate/ salmeterol combination 50/500mcg
Other Intervention Name(s)
Tiotropium bromide 18mcg
Primary Outcome Measure Information:
Title
Rate of healthcare utilisation based exacerbations of COPD
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Grimmenstein
ZIP/Postal Code
A-2840
Country
Austria
Facility Name
GSK Investigational Site
City
Moedling
ZIP/Postal Code
A-2340
Country
Austria
Facility Name
GSK Investigational Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1120
Country
Austria
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
GSK Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GSK Investigational Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Blansko
ZIP/Postal Code
678 31
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Kyjov
ZIP/Postal Code
697 33
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Olomouc
ZIP/Postal Code
775 25
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
703 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Plzen
ZIP/Postal Code
301 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Plzen
ZIP/Postal Code
326 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 4
ZIP/Postal Code
140 46
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Aalborg
ZIP/Postal Code
DK-9100
Country
Denmark
Facility Name
GSK Investigational Site
City
Aarhus C
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
GSK Investigational Site
City
Kobenhavn NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
GSK Investigational Site
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
GSK Investigational Site
City
Paide
ZIP/Postal Code
72712
Country
Estonia
Facility Name
GSK Investigational Site
City
Parnu
ZIP/Postal Code
80024
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
1162
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
13619
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
Country
Estonia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
GSK Investigational Site
City
Weinheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69469
Country
Germany
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86156
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Kissingen
State/Province
Bayern
ZIP/Postal Code
97688
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Toelz
State/Province
Bayern
ZIP/Postal Code
83646
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Woerrishofen
State/Province
Bayern
ZIP/Postal Code
86825
Country
Germany
Facility Name
GSK Investigational Site
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91052
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80335
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81677
Country
Germany
Facility Name
GSK Investigational Site
City
Eschwege
State/Province
Hessen
ZIP/Postal Code
37269
Country
Germany
Facility Name
GSK Investigational Site
City
Gelnhausen
State/Province
Hessen
ZIP/Postal Code
63571
Country
Germany
Facility Name
GSK Investigational Site
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34117
Country
Germany
Facility Name
GSK Investigational Site
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34121
Country
Germany
Facility Name
GSK Investigational Site
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
Facility Name
GSK Investigational Site
City
Bielefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33602
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10178
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10585
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10965
Country
Germany
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
15669
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
184 54
Country
Greece
Facility Name
GSK Investigational Site
City
Chania, Crete
ZIP/Postal Code
73300
Country
Greece
Facility Name
GSK Investigational Site
City
Heraklion, Crete
ZIP/Postal Code
71409
Country
Greece
Facility Name
GSK Investigational Site
City
Kavala
Country
Greece
Facility Name
GSK Investigational Site
City
Periohi Dragana, Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
GSK Investigational Site
City
Rethymnon, Crete
ZIP/Postal Code
74100
Country
Greece
Facility Name
GSK Investigational Site
City
Eboli (SA)
State/Province
Campania
ZIP/Postal Code
84025
Country
Italy
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Salerno
State/Province
Campania
ZIP/Postal Code
84126
Country
Italy
Facility Name
GSK Investigational Site
City
Telese (BN)
State/Province
Campania
ZIP/Postal Code
82037
Country
Italy
Facility Name
GSK Investigational Site
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Facility Name
GSK Investigational Site
City
Rivolta d'Adda (CR)
State/Province
Lombardia
ZIP/Postal Code
26026
Country
Italy
Facility Name
GSK Investigational Site
City
Sesto San Giovanni (MI)
State/Province
Lombardia
ZIP/Postal Code
20099
Country
Italy
Facility Name
GSK Investigational Site
City
Ascoli Piceno
State/Province
Marche
ZIP/Postal Code
63100
Country
Italy
Facility Name
GSK Investigational Site
City
Cassano Murge (BA)
State/Province
Puglia
ZIP/Postal Code
70020
Country
Italy
Facility Name
GSK Investigational Site
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71100
Country
Italy
Facility Name
GSK Investigational Site
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
GSK Investigational Site
City
San Sisto (PG)
State/Province
Umbria
ZIP/Postal Code
06132
Country
Italy
Facility Name
GSK Investigational Site
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
GSK Investigational Site
City
Jekabpils
ZIP/Postal Code
LV 5201
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1035
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV1079
Country
Latvia
Facility Name
GSK Investigational Site
City
Alytus
ZIP/Postal Code
LT-62114
Country
Lithuania
Facility Name
GSK Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
GSK Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-92231
Country
Lithuania
Facility Name
GSK Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
GSK Investigational Site
City
Vilnius
ZIP/Postal Code
LT-07156
Country
Lithuania
Facility Name
GSK Investigational Site
City
's-HERTOGENBOSCH
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
GSK Investigational Site
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
GSK Investigational Site
City
Almere
ZIP/Postal Code
1315 RA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amersfoort
ZIP/Postal Code
3818 ES
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1034 CS
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
GSK Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
GSK Investigational Site
City
Hoorn
ZIP/Postal Code
1624 NP
Country
Netherlands
Facility Name
GSK Investigational Site
City
Leiderdorp
ZIP/Postal Code
2353 GA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Meppel
ZIP/Postal Code
7943 KA
Country
Netherlands
Facility Name
GSK Investigational Site
City
OSS
ZIP/Postal Code
5342 BT
Country
Netherlands
Facility Name
GSK Investigational Site
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
GSK Investigational Site
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
GSK Investigational Site
City
Weert
ZIP/Postal Code
6001 BE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Bergen
ZIP/Postal Code
5053
Country
Norway
Facility Name
GSK Investigational Site
City
Egsjordet
Country
Norway
Facility Name
GSK Investigational Site
City
Fredrikstad
ZIP/Postal Code
1606
Country
Norway
Facility Name
GSK Investigational Site
City
Gjettum
ZIP/Postal Code
N-1346
Country
Norway
Facility Name
GSK Investigational Site
City
Moelv
ZIP/Postal Code
2391
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
1150
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
855
Country
Norway
Facility Name
GSK Investigational Site
City
Tonsberg
ZIP/Postal Code
N-3117
Country
Norway
Facility Name
GSK Investigational Site
City
Trondheim
ZIP/Postal Code
N-7027
Country
Norway
Facility Name
GSK Investigational Site
City
Trondheim
ZIP/Postal Code
N-7030
Country
Norway
Facility Name
GSK Investigational Site
City
Volda
ZIP/Postal Code
6100
Country
Norway
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
050159
Country
Romania
Facility Name
GSK Investigational Site
City
Bucuresti
ZIP/Postal Code
70000
Country
Romania
Facility Name
GSK Investigational Site
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
GSK Investigational Site
City
Deva
ZIP/Postal Code
2700
Country
Romania
Facility Name
GSK Investigational Site
City
Iasi
ZIP/Postal Code
700115
Country
Romania
Facility Name
GSK Investigational Site
City
Irkutsk
ZIP/Postal Code
664005
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
105 077
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
105 229
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
119 881
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
197 089
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
811 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Facility Name
GSK Investigational Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Previdza
ZIP/Postal Code
971 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Facility Name
GSK Investigational Site
City
Hoče
ZIP/Postal Code
2311
Country
Slovenia
Facility Name
GSK Investigational Site
City
Litija
ZIP/Postal Code
1270
Country
Slovenia
Facility Name
GSK Investigational Site
City
Topolšica
ZIP/Postal Code
3326
Country
Slovenia
Facility Name
GSK Investigational Site
City
Alicante
Country
Spain
Facility Name
GSK Investigational Site
City
Barakaldo (Vizcaya)
ZIP/Postal Code
48903
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
GSK Investigational Site
City
Figueres
Country
Spain
Facility Name
GSK Investigational Site
City
Galdakano
ZIP/Postal Code
48960
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Facility Name
GSK Investigational Site
City
Orihuela (Alicante)
Country
Spain
Facility Name
GSK Investigational Site
City
Vic
ZIP/Postal Code
28500
Country
Spain
Facility Name
GSK Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
GSK Investigational Site
City
Eksjö
ZIP/Postal Code
SE-575 81
Country
Sweden
Facility Name
GSK Investigational Site
City
Karlstad
ZIP/Postal Code
SE-651 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Luleå
ZIP/Postal Code
SE-971 89
Country
Sweden
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
GSK Investigational Site
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
GSK Investigational Site
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Örebro
ZIP/Postal Code
SE-701 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Kiev - 112
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kiev
ZIP/Postal Code
3680
Country
Ukraine
Facility Name
GSK Investigational Site
City
Peterborough
State/Province
Cambridgeshire
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Liverpool
State/Province
Lancashire
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Isleworth
State/Province
Middlesex
ZIP/Postal Code
TW7 6AG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Edinburg
State/Province
Midlothian
ZIP/Postal Code
EH3 9YW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Newcastle Upon Tyne
State/Province
Northumberland
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Newcastle Upon Tyne
State/Province
Northumberland
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Warwickshire
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
E2 9JX
Country
United Kingdom
Facility Name
GSK Investigational Site

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
20576732
Citation
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.
Results Reference
background
PubMed Identifier
19098157
Citation
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.
Results Reference
background
PubMed Identifier
19657399
Citation
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.
Results Reference
background
PubMed Identifier
18713851
Citation
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.
Results Reference
background
PubMed Identifier
18565964
Citation
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.
Results Reference
background
PubMed Identifier
17916806
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SCO40036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SCO40036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SCO40036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SCO40036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SCO40036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SCO40036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SCO40036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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