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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00549146 |
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 |
Estimated Enrollment: | 290 |
Study Start Date: | November 2003 |
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.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
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 | |
HELMOND, Netherlands, 5707 HA | |
GSK Investigational Site | |
BLARICUM, Netherlands, 1261 AN | |
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 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SCO40055, SER 0302 / SICLONE |
Study First Received: | October 24, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00549146 |
Health Authority: | Netherlands: Centrale Commissie Mensgebonden Onderzoek |
COPD reversibility lung function |
Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Fluticasone Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Anti-Allergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |