Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
fluticasone propionate/salmeterol combination, tiotropium, SERETIDE, COPD exacerbation
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)
Interventions
DRUGFluticasone propionate/ salmeterol combination 50/500mcg
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of healthcare utilisation based exacerbations of COPD | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria, Belgium, Czechia, Denmark, Estonia, Germany, Greece, Italy, Latvia, Lithuania, Netherlands, Norway, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Ukraine, United Kingdom
Outcome results
None listed