Last updated: 11/04/2018 11:56:17
SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Tiotropium bromide 18mcg
Drug: Fluticasone propionate/ salmeterol combination 50/500mcg
Enrollment:
1270
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Calverley PM, Stockley RA, Seemungal TA, et al. Reported pneumonia in COPD: findings from the INSPIRE study. Chest 2010 Jun 24.
Chui D, Tejani AM. The INSPIRE trial results: are they truly breathtaking? Am J Respir Crit Care Med 2009;179(1):80; author reply 80–1.
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(2):253–63.
Lanes SF, Jara M. The INSPIRE study: influence of prior use and discontinuation of inhaled corticosteroids. Am J Respir Crit Care Med 2008;178(5):543–4; author reply 544.
Middleton PG. Management of patients with COPD: a comparison of the INSPIRE and TORCH studies. Am J Respir Crit Care Med 2008;178(1):106; author reply 106–7.
Wedzicha JA, Calverley PM, Seemungal TA, et al. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med 2008;177(1):19–26.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, tiotropium bromide
Collaborators
Not applicable
Study date(s)
June 2003 to February 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- Established clinical history of moderate to severe COPD.
- Post bronchodilator FEV1 of < 50% of predicted normal.
- 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).
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Bad Kissingen, Bayern, Germany, 97688
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Periohi Dragana, Alexandroupolis, Greece, 68100
Status
Study Complete
Location
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE7 7DN
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G4 0SF
Status
Study Complete
Location
GSK Investigational Site
Rivolta d'Adda (CR), Lombardia, Italy, 26026
Status
Study Complete
Location
GSK Investigational Site
Edinburg, Midlothian, United Kingdom, EH3 9YW
Status
Study Complete
Location
GSK Investigational Site
Peterborough, Cambridgeshire, United Kingdom, PE3 6DA
Status
Study Complete
Location
GSK Investigational Site
Cassano Murge (BA), Puglia, Italy, 70020
Status
Study Complete
Location
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE1 4LP
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M8 5RB
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Warwickshire, United Kingdom, B15 2TH
Status
Study Complete
Location
GSK Investigational Site
Sesto San Giovanni (MI), Lombardia, Italy, 20099
Status
Study Complete
Location
GSK Investigational Site
's-HERTOGENBOSCH, Netherlands, 5211 NL
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Lancashire, United Kingdom, L9 7AL
Status
Study Complete
Location
GSK Investigational Site
Isleworth, Middlesex, United Kingdom, TW7 6AG
Status
Study Complete
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33602
Status
Study Complete
Location
GSK Investigational Site
Bad Woerrishofen, Bayern, Germany, 86825
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-19-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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