SERETIDE Plus Tiotropium Versus Individual Components - Tabular View

Tracking Information

First Received Date ^ICMJE

May 10, 2006

Last Updated Date

June 19, 2007

Start Date ^ICMJE

December 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00325169 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

SERETIDE Plus Tiotropium Versus Individual Components

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Drug: Tiotropium + SERETIDE 50/500

Study Arms / Comparison Groups

Publications *

Singh D, Brooks J, Hagan G, Cahn A, O'Connor BJ. Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD. Thorax. 2008 Jul;63(7):592-8. Epub 2008 Feb 1.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

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).

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00325169

Responsible Party

Study ID Numbers ^ICMJE

SCO104962

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP