Status:
COMPLETED
SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
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 obstructiv...
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 Tiotr...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
1270 Patients enrolled
Trial Details
Trial ID
NCT00361959
Start Date
June 1 2003
End Date
February 1 2006
Last Update
January 20 2017
Active Locations (166)
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1
GSK Investigational Site
Grimmenstein, Austria, A-2840
2
GSK Investigational Site
Mödling, Austria, A-2340
3
GSK Investigational Site
Salzburg, Austria, A-5020
4
GSK Investigational Site
Vienna, Austria, A-1120