SERETIDE Plus Tiotropium Versus Individual Components

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00325169
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.

Detailed Description

A randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of SERETIDE™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg alone and SERETIDE 50/500mcg alone) in the treatment of subjects with COPD

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-05-10
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-12
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Has an established clinical history of COPD as defined as per the GOLD definition.
• Post-bronchodilator FEV1 of >30% to 75% of predicted normal at Visit 1, a post-bronchodilator FEV1 / FVC ratio = 70%.
• Current or ex-smoker with a smoking history of > 10 pack-years.

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Exclusion Criteria

• Has unstable COPD (Chronic Obstructive Pulmonary Disease).
• Has a current medical diagnosis of asthma and/or allergic rhinitis or know respiratory disorders (lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as > 12 hours oxygen use per day).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
AUC (0-4hrs, sGAW after morning dose of medication at day 14)

Secondary Outcome Measures

Name	Time	Method
Effects of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments on further elements of lung function, dyspnoea, symptoms and a patient/physician assessment of treatment effect.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom