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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00269087
First received: December 21, 2005
Last updated: October 13, 2008
Last verified: October 2008
History of Changes
  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
Chronic Obstructive Pulmonary Disease (COPD)
 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:

U.S. FDA Resources

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269087

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00269087     History of Changes
Other Study ID Numbers: SCO100648
Study First Received: December 21, 2005
Last Updated: October 13, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
COPD
Chronic Bronchitis
Emphysema

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes
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

ClinicalTrials.gov processed this record on June 18, 2013