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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Tiotropium bromide 18mcg
* Drug: Fluticasone propionate/ salmeterol combination 50/500mcg


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tiotropium bromide 18mcg|nan|
|Drug: Fluticasone propionate/ salmeterol combination 50/500mcg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of healthcare utilisation based exacerbations of COPD |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluticasone propionate/salmeterol combination, tiotropium, SERETIDE, COPD exacerbation