SERETIDE Plus Tiotropium Versus Individual Components - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Tiotropium + SERETIDE 50/500	Phase II

MedlinePlus related topics:

Breathing Problems COPD (Chronic Obstructive Pulmonary Disease)

ChemIDplus related topics:

Tiotropium Tiotropium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	48
Study Start Date:	December 2005

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325169

Locations


Belgium
	GSK Clinical Trials Call Center
	Gent, Belgium, 9000

United Kingdom
	GSK Clinical Trials Call Center
	Manchester, United Kingdom, M23 9LT
	GSK Clinical Trials Call Center
	London, United Kingdom, SE5 9PJ
	GSK Clinical Trials Call Center
	Southampton, United Kingdom, SO16 6YD
	GSK Clinical Trials Call Center
	London, United Kingdom, NW3 2QG

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical trials, MD	GlaxoSmithKline

More Information

Publications indexed to this study:

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.

Study ID Numbers:	SCO104962
First Received:	May 10, 2006
Last Updated:	June 19, 2007
ClinicalTrials.gov Identifier:	NCT00325169
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

COPD

Plethysmography

Impulse oscillometry

Dyspnoea

Cross-over

SERETIDE 50/500

Tiotropium

Triple

Study placed in the following topic categories:

Lung Diseases, Obstructive

Respiratory Tract Diseases

Bromides

Lung Diseases

Tiotropium

Dyspnea

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Parasympatholytics

Respiratory System Agents

Neurotransmitter Agents

Cholinergic Antagonists

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Cholinergic Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00325169