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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00269087
First received: December 21, 2005
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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)
Intervention Details:
    Drug: fluticasone propionate/salmeterol combination DISKUS
    Other Name: fluticasone propionate/salmeterol combination DISKUS
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00269087

Locations
Japan
GSK Investigational Site
Kodaira, Japan, 187-0002
Spain
GSK Investigational Site
Unknown, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00269087     History of Changes
Other Study ID Numbers: SCO100648
Study First Received: December 21, 2005
Last Updated: May 22, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Chronic Bronchitis
COPD
Emphysema

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Chronic Disease
Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Fluticasone
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on October 29, 2014