Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00549146
First received: October 24, 2007
Last updated: April 11, 2013
Last verified: February 2011
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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 |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: fluticasone propionate/salmeterol 250/50 DISKUS combination product Drug: fluticasone propionate DISKUS 500mcg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | See Detailed Description |
Resource links provided by NLM:
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 |
Intervention Details:
Detailed Description:
-
Drug: fluticasone propionate/salmeterol 250/50 DISKUS combination product
Drug: fluticasone propionate DISKUS 500mcg
- fluticasone propionate DISKUS 500mcg
- fluticasone propionate/salmeterol 250/50 DISKUS combination product
Other Names:
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 | |
| Alkmaar, Netherlands, 1815 JD | |
| GSK Investigational Site | |
| Almelo, Netherlands, 7609 PP | |
| GSK Investigational Site | |
| Amsterdam, Netherlands, 1091 AC | |
| GSK Investigational Site | |
| Amsterdam, Netherlands, 1034 CS | |
| GSK Investigational Site | |
| Amsterdam, Netherlands, 1058 NR | |
| GSK Investigational Site | |
| Drachten, Netherlands, 9202 NN | |
| GSK Investigational Site | |
| Haarlem, Netherlands, 2012 CE | |
| GSK Investigational Site | |
| Harderwijk, Netherlands, 3844 DG | |
| GSK Investigational Site | |
| Hengelo, Netherlands, 7555 DL | |
| GSK Investigational Site | |
| Hoorn, Netherlands, 1624 NP | |
| GSK Investigational Site | |
| Leeuwarden, Netherlands, 8934 AD | |
| GSK Investigational Site | |
| Meppel, Netherlands, 7943 KA | |
| GSK Investigational Site | |
| Nijmegen, Netherlands, 6532 SZ | |
| GSK Investigational Site | |
| Rotterdam, Netherlands, 3045 PM | |
| GSK Investigational Site | |
| Sneek, Netherlands, 8601 ZK | |
| GSK Investigational Site | |
| Utrecht, Netherlands, 2584 CX | |
| GSK Investigational Site | |
| Voerendaal, Netherlands, 6367 ED | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00549146 History of Changes |
| Other Study ID Numbers: | SCO40055 |
| Study First Received: | October 24, 2007 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Netherlands: Centrale Commissie Mensgebonden Onderzoek |
Keywords provided by GlaxoSmithKline:
|
reversibility COPD lung function |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Salmeterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013