GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: December 21, 2005
Last updated: January 16, 2017
Last verified: January 2017
This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: fluticasone propionate/salmeterol combination DISKUS
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)" A Long-term Treatment Study of GW815SF50/500µg in Chronic Obstructive Pulmonary Disease -

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • All AEs occurring in the period from the start of the treatment period until the end of follow-up period will be classified by the body system, and the nature, incidence, and time of onset and severity of AEs will be assessed. [ Time Frame: throughout study ]

Secondary Outcome Measures:
  • Laboratory tests [ Time Frame: throughout study ]
  • 12-lead ECG [ Time Frame: throughout study ]
  • Physical examinations [ Time Frame: throughout study ]
  • Oropharyngeal examination [ Time Frame: throughout study ]
  • Change in morning PEF, changes in pre-dose FVC, V50 and V25 [ Time Frame: throughout study ]
  • Use of rescue medication [ Time Frame: throughout study ]
  • Changes in symptom scores [ Time Frame: throughout study ]

Enrollment: 122
Study Start Date: January 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Diagnosis of COPD.

Exclusion criteria:

  • Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
  • Other inclusion and exclusion criteria will be evaluated at the first study visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00269087

GSK Investigational Site
Kodaira, Japan, 187-0002
GSK Investigational Site
Kyoto, Japan, 612-0026
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

This study has not been published in the scientific literature.

Responsible Party: GlaxoSmithKline Identifier: NCT00269087     History of Changes
Other Study ID Numbers: SCO100648 
Study First Received: December 21, 2005
Last Updated: January 16, 2017

Keywords provided by GlaxoSmithKline:
Chronic Bronchitis

Additional relevant MeSH terms:
Pulmonary Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Bronchitis, Chronic
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents processed this record on January 19, 2017