Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00549146

Purpose

Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: fluticasone propionate/salmeterol 250/50 DISKUS combination product Drug: fluticasone propionate DISKUS 500mcg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.

Secondary Outcome Measures:

Reversibility of lung function with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50).

Estimated Enrollment:	290
Study Start Date:	November 2003

Detailed Description:

Multi-centre, double-blind, randomised and stratified parallel group study to compare the efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone combination 50/250 mcg bd both via Diskus inhaler during 1 year in Chronic Obstructive Pulmonary Disease(COPD) patients with a partially reversible obstruction.

Eligibility

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

Criteria

Inclusion criteria:

Established history of chronic obstructive pulmonary disease (COPD).
Lung function parameters: FEV1/FVC ratio < 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL.
Signed and dated informed consent.

Exclusion criteria:

History of asthma or allergy.
Unstable COPD in the 3 months before the study.
Interference of non-pulmonary medication or diseases with COPD outcome parameters.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549146

Locations

Netherlands
GSK Investigational Site
VELDHOVEN, Netherlands, 5504 DB
GSK Investigational Site
EINDHOVEN, Netherlands, 5623 EJ
GSK Investigational Site
RIJSWIJK, Netherlands, 2282 EP
GSK Investigational Site
EDE, Netherlands, 6716 RP
GSK Investigational Site
HAARLEM, Netherlands, 2035 RC
GSK Investigational Site
DEN HAAG, Netherlands, 2517 EW
GSK Investigational Site
AMSTERDAM, Netherlands, 1034 CS
GSK Investigational Site
DEN HAAG, Netherlands, 2545 CH
GSK Investigational Site
NIJMEGEN, Netherlands, 6532 SZ
GSK Investigational Site
DRACHTEN, Netherlands, 9202 NN
GSK Investigational Site
HENGELO, Netherlands, 7555 DL
GSK Investigational Site
ALMELO, Netherlands, 7609 PP
GSK Investigational Site
DEN HAAG, Netherlands, 2517 RW
GSK Investigational Site
VOERENDAAL, Netherlands, 6367 ED
GSK Investigational Site
HAARLEM, Netherlands, 2012 CE
GSK Investigational Site
AMSTERDAM, Netherlands, 1091 AC
GSK Investigational Site
ALKMAAR, Netherlands, 1815 JD
GSK Investigational Site
SNEEK, Netherlands, 8601 ZK
GSK Investigational Site
HARDERWIJK, Netherlands, 3844 DG
GSK Investigational Site
DEN HAAG, Netherlands, 2564 SJ
GSK Investigational Site
UBACHSBERG, Netherlands, 6367 JK
GSK Investigational Site
GRONINGEN, Netherlands, 9728 NZ
GSK Investigational Site
BLARICUM, Netherlands, 1261 AN
GSK Investigational Site
HELMOND, Netherlands, 5707 HA
GSK Investigational Site
WOERDEN, Netherlands, 3447 GN
GSK Investigational Site
VOORBURG, Netherlands, 2275 CX
GSK Investigational Site
LEEUWARDEN, Netherlands, 8934 AD
GSK Investigational Site
DORDRECHT, Netherlands, 3317 NM
GSK Investigational Site
ROTTERDAM, Netherlands, 3078 HT
GSK Investigational Site
DEN HAAG, Netherlands, 2597 AX
GSK Investigational Site
AMSTERDAM, Netherlands, 1058 NR
GSK Investigational Site
DEN BOSCH, Netherlands, 5211 RW
GSK Investigational Site
ROTTERDAM, Netherlands, 3045 PM
GSK Investigational Site
HOORN, Netherlands, 1624 NP
GSK Investigational Site
UTRECHT, Netherlands, 2584 CX
GSK Investigational Site
MEPPEL, Netherlands, 7943 KA

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SCO40055, SER 0302 / SICLONE
Study First Received:	October 24, 2007
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00549146 History of Changes
Health Authority:	Netherlands: Centrale Commissie Mensgebonden Onderzoek

Keywords provided by GlaxoSmithKline:

COPD
reversibility
lung function

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Salmeterol
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Respiration Disorders
Anti-Asthmatic Agents
Anti-Allergic Agents
Adrenergic Agonists

Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 30, 2009