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Home > Protocol Summaries: Compounds > salmeterol > Protocol Summary for 113095

Protocol Summary for 113095

Protocol Summary
Protocol Id: 113095
Secondary Ids:
  • N/A
Title: Special Drug Use Investigation for ADOAIR DISKUS COPD (salmeterol and fluticasone)
Phase: phase 4
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Observational
Oversight Authority:
  • Japan: Pharmaceuticals and Medical Devices Agency
Collaborators:
  • N/A
Brief Summary: To investigate possible problems or questions in safety and effectiveness of salmeterol and fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic / emphysema). In this special drug use investigation, onset of pneumonia shall be handled as the priority investigation item.
Detailed Description:
Record Verification Date: January 2013
Status: Completed
Why Study Stopped:
Study Start Date: August 2009
Study Completion Date: January 2013
Study Completion Date Type: Actual
Primary Completion Date: April 2012
Primary Completion Date Type: Actual
Study Design: Other
Time Perspective: Prospective
Biospecimen Retention: None retained
Biospecimen Description:
Primary Outcomes:
  • The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice. 1 year
Secondary Outcomes:
Conditions:
  • Pulmonary Disease, Chronic Obstructive
Keywords:
Study Population: Patients who are diagnosed as having a chronic obstructive pulmonary disease (bronchitis chronic / emphysema)
Sampling Method: Probability
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age:
Maximum Age:
Enrollment: 2000
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information