SERETIDE Plus Tiotropium Versus Individual Components - Full Text View

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide Tiotropium

U.S. FDA Resources

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical trials, MD

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00325169 History of Changes
Other Study ID Numbers:	SCO104962
Study First Received:	May 10, 2006
Last Updated:	June 19, 2007
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

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Fluticasone, salmeterol drug combination
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on February 12, 2012