Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 7, 2011
CompletedFirst Posted
Study publicly available on registry
April 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJune 10, 2013
June 1, 2013
2.7 years
April 7, 2011
June 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Patients prescribed salmeterol and fluticasone
Patients with chronic obstructive pulmonary disease prescribed salmeterol and fluticasone during study period
Interventions
Administered according to the prescribing information in the locally approved label by the authorities.
Eligibility Criteria
Patients who are diagnosed as having a chronic obstructive pulmonary disease (bronchitis chronic / emphysema)
You may qualify if:
- Must use salmeterol and fluticasone for the first time
You may not qualify if:
- Patients with hypersensitivity to salmeterol and fluticasone
- Patients with infection which salmeterol and fluticasone is not effective
- Patients with deep mycosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Chiba, 296-8602, Japan
Related Publications (1)
Yoriko Morioka, Hiroharu Abe, Terufumi Hara, Pascal Yoshida. Post-marketing Surveillance of Salmeterol Xinafoate / Fluticasone Propionate (Adoair®250Diskus®) - Interim Report -. Resp Med - Kokyuki Naika. 2013;23(1):111-122.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2011
First Posted
April 11, 2011
Study Start
August 1, 2009
Primary Completion
April 1, 2012
Study Completion
January 1, 2013
Last Updated
June 10, 2013
Record last verified: 2013-06