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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Fluticasone propionate/ salmeterol combination 50/500mcg

Drug: Tiotropium bromide 18mcg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00361959

SCO40036

Details and patient eligibility

About

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.

Full 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)

Enrollment

1,270 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No 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).