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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361959
• Other study ID #: SCO40036
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2006
• Last updated: January 19, 2017
• Start date: June 2003
• Est. completion date: February 2006

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1270
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium bromide 18mcg

• Fluticasone propionate/ salmeterol combination 50/500mcg

Locations

Country	Name	City	State
	GSK Investigational Site
Austria	GSK Investigational Site	Grimmenstein
Austria	GSK Investigational Site	Moedling
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Vienna
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liège
Czech Republic	GSK Investigational Site	Blansko
Czech Republic	GSK Investigational Site	Kyjov
Czech Republic	GSK Investigational Site	Olomouc
Czech Republic	GSK Investigational Site	Ostrava
Czech Republic	GSK Investigational Site	Plzen
Czech Republic	GSK Investigational Site	Plzen
Czech Republic	GSK Investigational Site	Praha 4
Czech Republic	GSK Investigational Site	Praha 8
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Aarhus C
Denmark	GSK Investigational Site	Kobenhavn NV
Denmark	GSK Investigational Site	Odense C
Estonia	GSK Investigational Site	Paide
Estonia	GSK Investigational Site	Parnu
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Kissingen	Bayern
Germany	GSK Investigational Site	Bad Toelz	Bayern
Germany	GSK Investigational Site	Bad Woerrishofen	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bielefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Erlangen	Bayern
Germany	GSK Investigational Site	Eschwege	Hessen
Germany	GSK Investigational Site	Gelnhausen	Hessen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Marburg	Hessen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Greece	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
Italy	GSK Investigational Site	Ascoli Piceno	Marche
Italy	GSK Investigational Site	Cassano Murge (BA)	Puglia
Italy	GSK Investigational Site	Eboli (SA)	Campania
Italy	GSK Investigational Site	Ferrara	Emilia-Romagna
Italy	GSK Investigational Site	Foggia	Puglia
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Rivolta d'Adda (CR)	Lombardia
Italy	GSK Investigational Site	Salerno	Campania
Italy	GSK Investigational Site	San Sisto (PG)	Umbria
Italy	GSK Investigational Site	Sesto San Giovanni (MI)	Lombardia
Italy	GSK Investigational Site	Telese (BN)	Campania
Latvia	GSK Investigational Site	Jekabpils
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Lithuania	GSK Investigational Site	Alytus
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Klaipeda
Lithuania	GSK Investigational Site	Klaipeda
Lithuania	GSK Investigational Site	Vilnius
Netherlands	GSK Investigational Site	's-HERTOGENBOSCH
Netherlands	GSK Investigational Site	Almelo
Netherlands	GSK Investigational Site	Almere
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
Norway	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	Tonsberg
Norway	GSK Investigational Site	Trondheim
Norway	GSK Investigational Site	Trondheim
Norway	GSK Investigational Site	Volda
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucuresti
Romania	GSK Investigational Site	Cluj-Napoca
Romania	GSK Investigational Site	Deva
Romania	GSK Investigational Site	Iasi
Russian Federation	GSK Investigational Site	Irkutsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St. Petersburg
Slovakia	GSK Investigational Site	Bardejov
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Previdza
Slovenia	GSK Investigational Site	Golnik
Slovenia	GSK Investigational Site	Hoce
Slovenia	GSK Investigational Site	Litija
Slovenia	GSK Investigational Site	Topolšica
Spain	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
Sweden	GSK Investigational Site	Eksjö
Sweden	GSK Investigational Site	Karlstad
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Luleå
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Örebro
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Uppsala
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kiev - 112
United Kingdom	GSK Investigational Site	Birmingham	Warwickshire
United Kingdom	GSK Investigational Site	Edinburg	Midlothian
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Isleworth	Middlesex
United Kingdom	GSK Investigational Site	Liverpool	Lancashire
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester	Lancashire
United Kingdom	GSK Investigational Site	Newcastle Upon Tyne	Northumberland
United Kingdom	GSK Investigational Site	Newcastle Upon Tyne	Northumberland
United Kingdom	GSK Investigational Site	Peterborough	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Denmark,  Estonia,  Germany,  Greece,  Italy,  Latvia,  Lithuania,  Netherlands,  Norway,  Romania,  Russian Federation,  Slovakia,  Slovenia,  Spain,  Sweden,  Ukraine,  United Kingdom, 

References & Publications (6)

Calverley PM, Stockley RA, Seemungal TA, 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):505-12. doi: 10.1378/chest.09-2992. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of healthcare utilisation based exacerbations of COPD
Secondary	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

External Links

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